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PT. PELITA BIOMEDICAL

Authorized Representative in Indonesia

Jl. Dr. Saharjo No. 181C Lt. 2 RT.004/RW.003, Kode Pos 12860, Desa/Kelurahan Manggarai Selatan, Kec. Tebet, Kota Jakarta Selatan, Prov. DKI Jakarta
16 Products Represented
9 Manufacturers
Total Products
16
Manufacturers
9
Product Classes
1
Risk Classes
2
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : B
11 products
68.8%
Kelas Resiko : C
5 products
31.3%
All Represented Products (16)
Complete portfolio registered with BPOM

IWIN Negative Pressure Drainage Catheter for Single-Use

Manufacturer:

JIANGSU YANGTZE RIVER MEDICAL TECHNOLOGY CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

SINAPI Urine Meter SUM500V2

Manufacturer:

SINAPI BIOMEDICAL PTY. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2024

SINAPI Chest Drain XL 1000S

Manufacturer:

SINAPI BIOMEDICAL PTY. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2024

EXACTA NUMBER ONE Silicone Ballon Infuser NMB

Manufacturer:

GAMASTECH SRL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2024

SINAPI Chest Drain XL 200SC

Manufacturer:

SINAPI BIOMEDICAL CC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

SINAPI Chest Drain XL 2000SD

Manufacturer:

SINAPI BIOMEDICAL CC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2024

SINAPI Chest Drain XL 1000SC

Manufacturer:

SINAPI BIOMEDICAL CC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

Exacta Number One BOL

Manufacturer:

GAMASTECH SRL

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2024

ISOMED Vein Strippers

Manufacturer:

ISOMED S.A.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 7, 2024

IN-PORT Polymer Access Port

Manufacturer:

ISOMED S.A.R.L

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

INFU KT - Titanium Access Port Pression Injection

Manufacturer:

ISOMED S.A.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2022

ISOMED Huber Needle with extension

Manufacturer:

ISO MED S.A.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2022

EM-Embolectomy Catheter Dual/Double Lumen, Over The Wire

Manufacturer:

Z.T.S. HAGMED ZAJĄC I TOMASZEWSKI SP. J.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 29, 2020

EM-Embolectomy Catheter ( Single Lumen )

Manufacturer:

Z.T.S. HAGMED ZAJĄC I TOMASZEWSKI SP. J.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2020

ATOVEN Laser Surgical Apparatus

Manufacturer:

DIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 3, 2020

SINAPI Chest Drain XS50

Manufacturer:

SINAPI BIOMEDICAL CC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 11, 2019

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

Last updated: December 2025