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.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
QIAGEN SCIENCES LLCCountry of Origin
United States
Authorized Representative
PT. INODIAAR 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).
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