Pure Global

COBAS S2 Fluid Pack - Indonesia BPOM Medical Device Registration

COBAS S2 Fluid Pack is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101612959. The device is manufactured by ROCHE DIAGNOSTICS INTERNATIONAL, LTD. from Switzerland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. 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 : B
COBAS S2 Fluid Pack
Analysis ID: AKL 20101612959

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Switzerland

Authorized Representative

PT. ROCHE INDONESIA

AR Address

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

Registration Date

Feb 06, 2025

Expiry Date

Sep 04, 2029

Product Type

Clinical Chemistry Test System

Calibrator (cair)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from ROCHE DIAGNOSTICS INTERNATIONAL, LTD.
Products from the same manufacturer (2 products)