Pure Global

QUANTA LITE ß2GPI IgM ELISA - Indonesia BPOM Medical Device Registration

QUANTA LITE ß2GPI IgM ELISA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220436. The device is manufactured by INOVA DIAGNOSTICS, INC A WERFEN COMPANY from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DEMKA SAKTI.

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
QUANTA LITE ß2GPI IgM ELISA
Analysis ID: AKL 20305220436

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. DEMKA SAKTI

AR Address

Jl. Tanah Abang III No. 19 A - B, Jakarta Pusat

Registration Date

Sep 29, 2022

Expiry Date

Dec 31, 2024

Product Type

Immunological Test System

Beta -2-glycoprotein I immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing