Pure Global

LumiraDx D-Dimer Quality Controls - Indonesia BPOM Medical Device Registration

LumiraDx D-Dimer Quality Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208128082. The device is manufactured by LUMIRADX UK LIMITED. (DUMYAT) from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEDQUEST GLOBAL PARTNERS.

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
LumiraDx D-Dimer Quality Controls
Analysis ID: AKL 20208128082

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United Kingdom

Authorized Representative

PT. MEDQUEST GLOBAL PARTNERS

AR Address

MENARA SALEMBA LANTAI 7, JALAN SALEMBA RAYA NOMOR 5-5A

Registration Date

Jun 24, 2023

Expiry Date

Jan 01, 2028

Product Type

Hematological Reagents

Hematology quality control mixture.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing