CleanCell M - Indonesia BPOM Medical Device Registration
CleanCell M is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204320386. The device is manufactured by ROCHE DIAGNOSTICS (SUZHOU) LTD from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is ROCHE INDONESIA.
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Risk Classification
Product Class
Kelas : 1
Manufacturer
ROCHE DIAGNOSTICS (SUZHOU) LTDCountry of Origin
China
Authorized Representative
ROCHE INDONESIAAR Address
Gedung AIA Central Lantai 36 Jl. Jend. Sudirman KAV. 48A RT/RW 003/004 Kelurahan Karet Semanggi
Registration Date
Feb 13, 2023
Expiry Date
Oct 24, 2027
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
ELECSYS HCG+ฮฒ
VENTANA Bluing Reagent
Elecsys T3
Elecsys FSH
Elecsys Tg II
Elecsys FT3 III
Elecsys T4
COBAS Elecsys Free PSA
ELECSYS HE4 Elecsys and cobas e analyzers
Elecsys Myoglobin
Elecsys Anti-SARS-CoV-2 cobas e analyzers
ROCHE DIAGNOSTICS GMBH.
PreciControl Maternal Care
ROCHE DIAGNOSTICS GMBH
COAGUCHEK aPTT Test
ROCHE DIAGNOSTICS GMBH.
ROCHE TROP T Sensitive, Troponin T
ROCHE DIAGNOSTICS GMBH.
COBAS BM - Lactate
ROCHE DIAGNOSTICS GMBH.
ultraView Universal Alkaline Phosphatase Red Detection Kit
VENTANA MEDICAL SYSTEMS, INC.
COBAS Buffer Negative Control Kit for use on the cobas 6800/8800 Systems
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Wash Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Lysis Reagent
ROCHE MOLECULAR SYSTEMS INC.
COBAS omni Specimen Diluent
ROCHE MOLECULAR SYSTEMS INC.