Pure Global

AmniSure® ROM Test - Indonesia BPOM Medical Device Registration

AmniSure® ROM Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 11106023101. The device is manufactured by QIAGEN SCIENCES LLC from United States, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. INODIA.

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 : A
AmniSure® ROM Test
Analysis ID: AKL 11106023101

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Country of Origin

United States

Authorized Representative

PT. INODIA

AR Address

Perkantoran Kedoya Elok Plaza Blok DB no 24, Jalan Panjang, Kebon Jeruk

Registration Date

Jun 06, 2020

Expiry Date

Sep 11, 2024

Product Type

Diagnostic Obstetric and Gynaecological Equipment

Amniotic fluid sampler (amniocentesis tray).

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Other Products from QIAGEN SCIENCES LLC
Products from the same manufacturer (1 products)