Pure Global

EDAN Test Cartridge BM10 - Indonesia BPOM Medical Device Registration

EDAN Test Cartridge BM10 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101520251. The device is manufactured by EDAN INSTRUMENT, INC., from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NUSANTARA MEDCARE 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
EDAN Test Cartridge BM10
Analysis ID: AKL 20101520251

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. NUSANTARA MEDCARE INDONESIA

AR Address

NUSANTARA MEDCARE INDONESIA

Registration Date

Feb 04, 2025

Expiry Date

Jul 31, 2027

Product Type

Clinical Chemistry Test System

Blood gases (P CO 2, P O 2) and blood pH test system (card)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing