Pure Global

COBAS Pro ISE Analytical Unit and Accessories - Indonesia BPOM Medical Device Registration

COBAS Pro ISE Analytical Unit and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102912250. The device is manufactured by HITACHI HIGH-TECHNOLOGIES CORPORATION from Japan, 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 Pro ISE Analytical Unit and Accessories
Analysis ID: AKL 20102912250

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Japan

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

Dec 02, 2024

Expiry Date

Sep 26, 2028

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from HITACHI HIGH-TECHNOLOGIES CORPORATION
Products from the same manufacturer (1 products)