Pure Global

COBAS p501 and Accessories - Indonesia BPOM Medical Device Registration

COBAS p501 and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10102712699. The device is manufactured by ROCHE DIAGNOSTICS INTERNATIONAL LTD. from Switzerland, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is ROCHE INDONESIA.

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 : A
COBAS p501 and Accessories
Analysis ID: AKL 10102712699

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

Switzerland

Authorized Representative

ROCHE INDONESIA

AR Address

Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi

Registration Date

Sep 01, 2021

Expiry Date

Jun 24, 2026

Product Type

Clinical Laboratory Equipment

General purpose laboratory equipment labeled or promoted for a specific medical use.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing