Pure Global

OPTOPOL OPTICAL COHERENCE TOMOGRAPHY - Indonesia BPOM Medical Device Registration

OPTOPOL OPTICAL COHERENCE TOMOGRAPHY is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21201320383. The device is manufactured by OPTOPOL TECHNOLOOGY SP. Z. O.O from Poland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. KATAMATA OPTOMEDIK.

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
OPTOPOL OPTICAL COHERENCE TOMOGRAPHY
Analysis ID: AKL 21201320383

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Poland

Authorized Representative

PT. KATAMATA OPTOMEDIK

AR Address

Komplek Ketapang Indah Blok B2 No.31 Jl. KH. Zainul Arifin Kel.Krukut, Kec.Taman Sari Jakarta Barat

Registration Date

Oct 18, 2023

Expiry Date

Dec 05, 2027

Product Type

Diagnostic Eye Equipment

Optical Coherence Tomography

Non Radiation Electromedics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing