Pure Global

GensuPen 2 - Indonesia BPOM Medical Device Registration

GensuPen 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20902021938. The device is manufactured by BIOTON S.A. from Poland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BRIDGE TWO.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
GensuPen 2
Analysis ID: AKL 20902021938

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOTON S.A.

Country of Origin

Poland

Authorized Representative

PT. BRIDGE TWO

AR Address

Petojo Melintang No. 17 Kel. Petojo Selatan, Kec. Gambir Jakarta Pusat

Registration Date

Mar 22, 2022

Expiry Date

Feb 14, 2025

Product Type

Therapeutic General and Individual Hospital Equipment

Hypodermic single lumen needle.

Non Electromedic Non Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing