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PRO-HEALTH INTERNATIONAL

Authorized Representative in Indonesia

Komplek Perkantoran Duta Merlin Blok C 35-36, Jl. Gajah Mada 3-5 RT 002 RW 005, Prov. DKI Jakarta, Kota Jakarta Pusat, Kec. Gambir, Kel. Petojo Utara
52 Products Represented
18 Manufacturers
Total Products
52
Manufacturers
18
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
13 products
25.0%
Kelas Resiko : B
19 products
36.5%
Kelas Resiko : C
19 products
36.5%
Kelas Resiko : D
1 products
1.9%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (52)
Complete portfolio registered with BPOM

ACUMED Ankle Syndesmosis Repair System (Acu-Sinch Knotless)

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 23, 2025

OverStitch NXT™ Endoscopic Suturing System

Manufacturer:

VIANT MEDICAL, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2025

ACUMED Polarus 3 Solution System Nails

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 12, 2025

BEAR Medic TAMAI Disposable Microvascular Clamp

Manufacturer:

BEAR MEDIC CORPORATION

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

HONGHUGAOXIANG Raney Clips Kit

Manufacturer:

BEIJING HONGHUGAOXIANG SCIENCE AND TECHNOLOGY DEVELOPMENT CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 30, 2024

PUSEN Medical Video Endoscope Image Processor PV220

Manufacturer:

ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2024

PUSEN Single Use Flexible Video Ureteroscope PU3033A

Manufacturer:

ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

PUSEN Single Use Flexible Video Ureteroscope PU3033AH

Manufacturer:

ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2024

PUSEN HD Medical Video Endoscope Image Processor

Manufacturer:

ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

PUSEN Single Use Flexible Video Ureteroscope PU3022A

Manufacturer:

ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

DELTA Spinal Arthroscopic Instrument Set

Manufacturer:

BEIJING DELTA MEDICAL SCIENCE & TECHNOLOGY CORP. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

PENTAX Medical Mobile Processor ONE-M

Manufacturer:

ONYX HEALTHCARE INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

DELTA ACL/PCL Arthroscopic Instrument Set

Manufacturer:

BEIJING DELTA MEDICAL SCIENCE & TECHNOLOGY CORP. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

DELTA Shoulder Arthroscopic Instrument Set

Manufacturer:

BEIJING DELTA MEDICAL SCIENCE & TECHNOLOGY CORP. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

PENTAX Medical Video Bronchoscope EB15-S01

Manufacturer:

PENTAX MEDICAL BULGARIA EOOD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

DELTA Arthroscopic Hand Instruments

Manufacturer:

BEIJING DELTA MEDICAL SCIENCE & TECHNOLOGY CORP. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

PENTAX MEDICAL Vivideo ENT Videoscope

Manufacturer:

DIGITAL ENDOSCOPY GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

ACUMED Fibula Nail 2 System Implant Sterile

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 18, 2023

ACUMED Anatomic Radial Head Solution 2 Implant

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2023

ACUMED Fibula Nail 2 System Instrument

Manufacturer:

ACUMED LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 28, 2023

ACUMED Fibula Nail 2 System Implant

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2023

ACUMED Scapula Congruent Bone Plate System

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 31, 2023

OSTEOMED Fast Flap Neuro Fixation System (Instrument)

Manufacturer:

OSTEOMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

OSTEOMED Fast Flap Neuro Fixation System (Screw)

Manufacturer:

OSTEOMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

OSTEOMED Fast Flap Neuro Fixation System (Plates)

Manufacturer:

OSTEOMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2022

OSTEOMED Drill Instruments Set

Manufacturer:

OSTEOMED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 16, 2022

OSTEOMED Sterile Drill Instruments Set

Manufacturer:

OSTEOMED LP.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 16, 2022

OSTEOMED Hand Plating System Instruments

Manufacturer:

OSTEOMED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 14, 2022

OSTEOMED Speaks-Fit

Manufacturer:

OSTEOMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

OSTEOMED 2.0 Orthognatic Instruments

Manufacturer:

OSTEOMED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2022

EXTREMILOCK Wrist Plating System (Instrument)

Manufacturer:

OSTEOMED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2022

EXTREMILOCK Wrist Plating System (Plate)

Manufacturer:

OSTEOMED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2022

EXTREMILOCK Foot Plating Systems

Manufacturer:

OSTEOMED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

ACUMED Scapula Plating System Instruments

Manufacturer:

ACUMED LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 25, 2022

ACUMED Pelvic Plating System (Plate)

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 8, 2022

ACUMED Elbow Plating System (Plate)

Manufacturer:

ACUMED LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 25, 2022

GHIATAS Beaded Breast Localization Wire

Manufacturer:

BARD REYNOSA S.A. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 10, 2022

DUALOK Breast Lesion Localization Wire

Manufacturer:

BARD REYNOSA S.A. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 10, 2022

GHIATAS Beaded Breast Localization Wire with Stiffened Section

Manufacturer:

BARD REYNOSA S.A. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 10, 2022

MR GHIATAS Beaded Breast Localization Wire

Manufacturer:

BARD REYNOSA S.A. DE C.V.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 8, 2022

SENOMARK ULTRA Breast Tissue Marker

Manufacturer:

MEDICAL INFUSION (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2022

GEL MARK ULTRA Breast Tissue Marker

Manufacturer:

MEDICAL INFUSION (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2022

SENOMARK UltraCor Breast Tissue Marker

Manufacturer:

MEDICAL INFUSION (THAILAND) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2022

ULTRACLIP Dual Trigger Breast Tissue Marker

Manufacturer:

BARD SHANNON LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2022

ULTRACOR TWIRL Breast Tissue Marker

Manufacturer:

BARD SHANNON LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2022

FASTABLE Titanium Suture Anchor

Manufacturer:

BEIJING DELTA MEDICAL SCIENCE & TECHNOLOGY CORP. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2022

OHIO Thoracic Vacuum Regulator

Manufacturer:

OHIO MEDICAL LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2022

TRUD Mucoadhesive Suspension for Topical Application to the Colorectal Tissue, Non-sterile

Manufacturer:

MDT INT'L SA

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 10, 2021

OverStitch Sx™ Endoscopic Suturing System

Manufacturer:

APOLLO ENDOSURGERY COSTA RICA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2021

OverTube™ Endoscopic Access System

Manufacturer:

APOLLO ENDOSURGERY COSTA RICA S.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2021

OHIO Oxygen & Air Flowmeter

Manufacturer:

OHIO MEDICAL LLC

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 15, 2021

OHIO Vacuum Regulators

Manufacturer:

OHIO MEDICAL LLC

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2021

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

Last updated: December 2025