DIRUI BF - WNF Dye - Indonesia BPOM Medical Device Registration
DIRUI BF - WNF Dye is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204127805. The device is manufactured by DIRUI INDUSTRIAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.
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.
Risk Classification
Product Class
Kelas : 1
Manufacturer
DIRUI INDUSTRIAL CO., LTD.Country of Origin
China
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
Oct 10, 2022
Expiry Date
Jun 14, 2025
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
DIRUI Negative Control for Urine Sediment Analyzer
DIRUI HbA1C-s
DIRUI Prothrombin Time Detection Kit
DIRUI Positive Control for Urine Sediment Analyzer
DIRUI LDH
DIRUI ALP
DIRUI C-REACTIVE PROTEIN REGENT KIT
DIRUI Focus
DIRUI CS-680 Auto-Chemistry Analyzer
DIRUI Control for Hematology Analyzer
SM MALB Reagent Kit
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SM Multi Control for Clinical Chemistry Analyzer Level 1
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SM TB-DCA Reagent Kit
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SM DB-DCA Reagent Kit
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SM โ 700 Automatic Chemistry Analyzer
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SM FC-73 Flow Cytometer and Accessories
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SM Control Hematology Analyzer for 3 Diff
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SM Control Hematology Analyzer for 5 Diff
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SM Control Hematology Analyzer for 5 Diff (Normal Level)
URIT MEDICAL ELECTRONIC CO., LTD
SM 420 Automatic Chemistry Analyzer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD

