MACCURA Coagulation Analyzer Wash Buffer B (Coa-Wash B) - Indonesia BPOM Medical Device Registration
MACCURA Coagulation Analyzer Wash Buffer B (Coa-Wash B) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10204918320. The device is manufactured by MACCURA BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. INDARUM ASTAGUNA.
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
MACCURA BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. INDARUM ASTAGUNAAR Address
Ruko Permata Boulevard Blok AQ, Jl. Pos Pengumben Raya No. 1, Jakarta โ 11630 Telp. : (021) 5872778, Fax. (021) 5872779
Registration Date
Dec 28, 2021
Expiry Date
Dec 31, 2024
Product Type
Reagents and Specimen Providers
General purpose reagent.
Invitro Diagnostics
VIRTUEDX HA Calibrator 5D
VIRTUEDX HA Normal Control 5D
VIRTUEDX HA-50 LH-5 Lysing Reagent A
VIRTUEDX HA-50 LD-5 Lysing Reagent A
VIRTUEDX HA-50 GD-5 Diluent A
VIRTUEDX HA-50 CC-5 Cell Clean A
MACCURA 25-OH Vitamin D Chemiluminescent Immunoassay Kit
VIRTUEDX HA-50 DD-5 Fluorescent Dye A
MACCURA Ferritin (CLIA)
MACCURA 25-OH Vitamin D Control Level 1
MACCURA Coagulation Quality Control Plasma (CQC) Level 2
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Coagulation Quality Control Plasma (CQC) Level 1
MACCURA BIOTECHNOLOGY CO., LTD.
ZECEN POClia Thyroid-stimulating Hormone (TSH)
TAIZHOU ZECEN BIOTECH CO., LTD.
ZECEN POCLia Free thyroxine (FT4)
TAIZHOU ZECEN BIOTECH CO., LTD.
ZECEN POClia 8 Automatic Chemiluminescence Immunoassay Analyzer
TAIZHOU ZECEN BIOTECH CO., LTD.
MACCURA Coagulation Quality Control Plasma (CQC) Level 1
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Coagulation Analyzer Wash Buffer A (Coa-Wash A)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA Automatic Coagulation Analyzer
MACCURA MEDICAL INSTRUMENT CO., LTD.
MACCURA Fibrinogen (FIB)
MACCURA BIOTECHNOLOGY CO., LTD.
MACCURA APTT
MACCURA BIOTECHNOLOGY CO., LTD.

