NORUDIA L- FABP - Indonesia BPOM Medical Device Registration
NORUDIA L- FABP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10101714186. The device is manufactured by SEKISUI MEDICAL CO., LTD. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SUMBERMITRA AGUNGJAYA.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
SEKISUI MEDICAL CO., LTD.Country of Origin
Japan
Authorized Representative
PT. SUMBERMITRA AGUNGJAYAAR Address
Gading Bukit Indah, Blok H/3 Kel Kelapa Gading Barat, Kec Kelapa Gading Jakarta Utara
Registration Date
Apr 23, 2022
Expiry Date
Mar 09, 2027
Product Type
Clinical Chemistry Test System
Fatty acids test system (kit & cair)
Invitro Diagnostics
BM Test HbA1c Control (High dan Low)
BM Test HbA1c Diluent
SEKISUI Glycated Albumin Control
NORUDIA GA
SEKISUI Cystatin C Control N
SEKISUI Cystatin C Calibrator N
NORUDIA GA Calibrator
SEKISUI L-FABP Control
NORUDIA L-FABP Calibrator
Atellica CH HDL Cholesterol Calibrator (HDLC CAL)
TMS 30i Automated Clinical Analyzer and Accesories
FANDF CO., LTD.
SEKISUI Nanopia KL-6 Calibrator
SEKISUI MEDICAL CO., LTD., TSUKUBA PLANT
CZECH Nanopia E Control
SEKISUI MEDICAL CO., LTD., TSUKUBA PLANT
SEKISUI Nanopia KL-6 Reagent 1
SEKISUI MEDICAL CO., LTD., TSUKUBA PLANT
SEKISUI Nanopia KL-6 Reagent 2
SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
NORUDIA U-ALB
SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT.
Q-MAY Factor Auto P-FDP Calibrator Type K
Q-MAY LABORATORY CORPORATION.
Q-MAY Factor Auto P-FDP Type K
Q-MAY LABORATORY CORPORATION
Q-MAY Factor Auto Common Diluent Type K
Q-MAY LABORATORY CORPORATION.
Q-MAY Multiple Sera A Type K
Q-MAY LABORATORY CORPORATION