NORUDIA U-ALB - Indonesia BPOM Medical Device Registration
NORUDIA U-ALB is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305513512. The device is manufactured by SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT. 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. TSUKUBA PLANT.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
Sep 08, 2023
Expiry Date
Aug 07, 2028
Product Type
Immunological Test System
Albumin immunological test system.
Invitro Diagnostics
SEKISUI Nanopia CRP
SEKISUI U-ALB Calibrator A for NORUDIA U-ALB
SEKISUI CRP Calibrator (Nanopia) C
SEKISUI U-ALB Control for Norudia U-ALB
SEKISUI CRP Calibrator (Nanopia) A
SEKISUI Apo B Auto N DAIICHI
SEKISUI Apo A-I Auto N DAIICHI
SEKISUI Autosera S TG-N 1
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 2
SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
SEKISUI Nanopia KL-6 Reagent 1
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
Q-MAY Multiple Sera N Type K
Q-MAY LABORATORY CORPORATION.