TECO Red D-Dimer - Indonesia BPOM Medical Device Registration
TECO Red D-Dimer is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20207022282. The device is manufactured by TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH from Germany, and is classified as Risk Class Kelas Resiko : C. 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 : 2
Country of Origin
Germany
Authorized Representative
PT. FAITHFUL MEDICAL GRACEAR Address
Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89
Registration Date
May 10, 2023
Expiry Date
Oct 10, 2027
Product Type
Haematology Package and Kit
Fibrinogen/fibrin degradation products assay.
Invitro Diagnostics
SM MALB Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM Multi Control for Clinical Chemistry Analyzer Level 1
URIT MEDICAL ELECTRONIC CO., LTD
SM TB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM DB-DCA Reagent Kit
URIT MEDICAL ELECTRONIC CO., LTD
SM – 700 Automatic Chemistry Analyzer
URIT MEDICAL ELECTRONIC CO., LTD
SM FC-73 Flow Cytometer and Accessories
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 3 Diff
URIT MEDICAL ELECTRONIC CO., LTD
SM Control Hematology Analyzer for 5 Diff
URIT MEDICAL ELECTRONIC CO., LTD
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