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PT. FAJAR SELARAS PARTNERS

Authorized Representative in Indonesia

RUKAN PULOGADUNG TRADE CENTRE (PTC) BLOK 8C NOMOR 28-29
111 Products Represented
22 Manufacturers
Total Products
111
Manufacturers
22
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
26 products
23.4%
Kelas Resiko : B
13 products
11.7%
Kelas Resiko : C
69 products
62.2%
Kelas Resiko : D
3 products
2.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (111)
Complete portfolio registered with BPOM

DELPHI II

Manufacturer:

CNS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 14, 2024

AnyPlusII Pedicle Screw System-6

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2024

AnyPlusII Pedicle Screw System-3

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2024

AnyPlus II Pedicle Screw System-7

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

AnyPlusII Pedicle Screw System-5

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 19, 2024

AnyPlusII Pedicle Screw System-4

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 17, 2024

IRENE Locking Plate System

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 2, 2024

AnyPlusII Pedicle Screw System-1

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

PYXIS 3D Titanium T-PLIF Cage (Sterile)

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

AnyPlusII Pedicle Screw System-2

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

JEIL Surgical Instrument

Manufacturer:

JEIL MEDICAL CORPORATION

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 13, 2024

JEIL MEDICAL Speedy Flap System

Manufacturer:

JEIL MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2024

ARIX System Bone Screw

Manufacturer:

JEIL MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 6, 2024

LEFORTE Neuro System Bone Plate

Manufacturer:

JEIL MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2024

ARIX System Bone Plate

Manufacturer:

JEIL MEDICAL CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 31, 2024

PULSAR Expandable Cage System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2024

ANYPLUS PEEK Cage System Instrument (TLIF)

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2024

LANTUO Bone Cement Injector

Manufacturer:

BEIJING LANTUO MEDICAL INSTRUMENT CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 11, 2024

PYXIS 3D Titanium TLIF Cage (Sterile)

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

JESWIS Electrolytic-plasma Electrosurgical Systems-Plasma Wand

Manufacturer:

BEIJING JESWIS TECHNOLOGY LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

JESWIS Electrolytic-plasma Electrosurgical Systems-Generator

Manufacturer:

BEIJING JESWIS TECHNOLOGY LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2024

PYXIS 3D Titanium OLIF Cage (Sterile)

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 5, 2024

PYXIS 3D Titanium PLIF Cage (Sterile)

Manufacturer:

GS MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

SPINE-FIX Radiopaque Bone Cement

Manufacturer:

TEKNIMED SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 24, 2024

TRAFAS Medical Electric Drill Saw

Manufacturer:

WUHU RUIJIN MEDICAL INSTRUMENT & DEVICE CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2024

TRAFAS Utomo Spine Manual Surgical Instrument (Non-Sterile)

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2024

TRAFAS Utomo Posterior Cervical Fixation System

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 17, 2024

ORTHOCEM 3 Surgical Cement Low Viscosity

Manufacturer:

TEKNIMED SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 13, 2024

ORTHOCEM 1 Surgical Cement Standard Viscosity

Manufacturer:

TEKNIMED SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

NANOGEL Synthetic Bone Substitute

Manufacturer:

TEKNIMED SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 7, 2024

IRENE Spinal Fixation System

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 2, 2024

EPINAUT

Manufacturer:

IMEDICOM CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2024

IRENE Instrument Set for DIAMOND Hip system (Total Hip)

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 4, 2024

IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 1)

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 28, 2024

IRENE Instrument Set

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 27, 2024

IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 2)

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 27, 2024

IRENE Instrument Set For 5.0mm Large Fragment Locking Plate System

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 3)

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

IRENE Instrument Set for DIAMOND Total Knee Replacement System (Box 4)

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

IRENE Instrument Set For 3.5mm Small Fragment Locking Plate System

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

IRENE Instrument Set For Screw Extraction

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 20, 2024

IRENE Joint Prosthesis

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 11, 2024

NAVIGATOR Intramedullary Nail System

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2024

IRENE Metal Bone Screws

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 21, 2024

IRENE Locking Plate System

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

IRENE Knee Prosthesis

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

IRENE Intramedullary Nail System (Titanium)

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

IRENE Locking Plate System

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

IRENE Locking Plate System

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 17, 2024

IRENE Metal Bone Screws

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 13, 2024

NAVIGATOR Intramedullary Nail System

Manufacturer:

TIANJIN ZHENG TIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 2, 2024

KYRA Correction Cord System

Manufacturer:

TRIA SPINE MEDIKAL A.S.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 15, 2024

QUASAR Stand-alone ACIF Cage

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2023

Tracker-X Balloon Catheter

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 13, 2023

TRACKER

Manufacturer:

GS MEDICAL CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 29, 2023

TRAFAS Utomo T-Lock Cervical Intervertebral Cage

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2023

Anyplus OLIF PEEK Cage

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 13, 2023

ROTAIO Instruments

Manufacturer:

SIGNUS MEDIZINTECHNIK GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 11, 2023

GS TRACKER - P

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 29, 2023

SPINAUT

Manufacturer:

IMEDICOM CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

XISHAN Surgical Power Device (DK-N-MS)

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

IMEDICOM ICD System (Medinaut-I, Medinaut-V)

Manufacturer:

IMEDICOM CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 11, 2023

XISHAN Surgical Power Device (DK-ENT-MS)

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

IMEDICOM Medinaut-X, Bone Expander Syringe

Manufacturer:

IMEDICOM CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 2, 2023

CASSIOPEIA Anterior Cervical Plate System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 3, 2023

MEDINAUT-X (IBE System) Balloon Catheter

Manufacturer:

IMEDICOM CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 27, 2023

CASSIOPEIA Anterior Cervical Plate System Instrument

Manufacturer:

GS MEDICAL CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 19, 2023

TRAFAS Utomo Spine Manual Surgical Instrument (Sterile)

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 29, 2023

DOLPHIN Laminoplasty System

Manufacturer:

TDM CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 26, 2023

SKY II Reconstruction System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2023

Anyplus OLIF PEEK Cage (Sterile)

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2023

GSS Pedicle Screw System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 3, 2023

GS MEDICAL Rod System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 31, 2023

XISHAN Single-use Sterile OP & ENT Shaving Blade

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2023

XISHAN Surgical Power Device DK-N-MP

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

XISHAN Single-use Steril Bur

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2023

XISHAN Single-use Sterile Cranial Perforator

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2023

ORTHOCEM 3G

Manufacturer:

TEKNIMED SAS.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Feb 7, 2023

TRAFAS Utomo PEEK Lumbar Intervertebral Cage

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2023

TRAFAS Utomo Nova Spinal Fixation System

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2023

XISHAN Single-use Steril Cutting Blade

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2023

TRAFAS Utomo Comet Lumbar Interbody Fusion Cage

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2023

TRAFAS Utomo Anterior Cervical Plate System

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2023

XISHAN Single-use Sterile OP & ENT Bur

Manufacturer:

CHONGQING XISHAN SCIENCE & TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

TRAFAS Utomo PEEK Cervical Intervertebral Cage

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 6, 2023

TDM Wire and Pin

Manufacturer:

TDM CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 26, 2022

ORTHOCEM 1G

Manufacturer:

TEKNIMED SAS.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 12, 2022

OPACITY + Radiopaque Bone Cement

Manufacturer:

TEKNIMED SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

CERAFORM Synthetic Bone Substitute

Manufacturer:

TEKNIMED SAS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

GSS Pedicle Screw System - Spinal Fixation System

Manufacturer:

GS MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 9, 2022

ANYPLUS Pedicle Screw System, Spinal Internal Fixation System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 8, 2022

SKY Reconstruction System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 8, 2022

GS MEDICAL Spinal Fixation System Instrument (Pedicle Screw)

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2022

TRAFAS Medical Electric Drill Saw

Manufacturer:

WUHU RUIJIN MEDICAL INSTRUMENT & DEVICE CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 25, 2022

TRAFAS Utomo Lumbar Fixation System

Manufacturer:

BAUI BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 21, 2022

ANYPLUS PEEK Cage System Instrument (PLIF)

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 30, 2022

IRENE Non-Locking Plate System

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 14, 2022

ANYPLUS Cervical PEEK Cage

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2022

ANYPLUS PLIF PEEK Cage

Manufacturer:

GS MEDICAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2022

GS MEDICAL Spinal Cage System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 23, 2022

ABEL Epidural Catheter System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2022

GSS Pedicle Screw System-Spinal Fixation System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 27, 2022

GS MEDICAL Tracker I

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 24, 2022

GS MEDICAL Tracker X Balloon Catheter

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2022

GS Growing Rod System

Manufacturer:

GS MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 19, 2022

IRENE Joint Prosthesis

Manufacturer:

TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 16, 2022

SHINVA Neuro Instrument Set

Manufacturer:

XINHUA SURGICAL INSTRUMENTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 11, 2021

SHINVA Orthopedic Surgical Instruments

Manufacturer:

XINHUA SURGICAL INSTRUMENTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 6, 2021

APIS Pedicle Screw System

Manufacturer:

TDM CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2021

F20 Radiopaque Bone Cement

Manufacturer:

TEKNIMED SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 31, 2020

MORPHO Cervical Plate Set

Manufacturer:

HPI

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025