COMBOSTIK 10M (Blood, Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Nitrite, Leukocytes, pH, Specific Gravity) - Indonesia BPOM Medical Device Registration
COMBOSTIK 10M (Blood, Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Nitrite, Leukocytes, pH, Specific Gravity) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101010117. The device is manufactured by DFI CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SABA INDOMEDIKA.
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
Manufacturer
DFI CO., LTD.Country of Origin
Korea
Authorized Representative
PT. SABA INDOMEDIKAAR Address
Ruko Kedoya Elok Plaza DB-33 Jl. Panjang No.7-9
Registration Date
Aug 19, 2024
Expiry Date
Jul 17, 2029
Product Type
Clinical Chemistry Test System
Multi parameter clinical chemistry test system
Invitro Diagnostics
COMBOSTIK 3 (Protein, pH, Glucose)
COMBOSTIK โข R-300 and Accessories
ComboStik 11M (Blood, Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Nitrite, Leukocytes, pH, Specific Gravity, Ascorbic Acid)
COMBOSTIK R-600S and Accessories
COMBOSTIK G
CYBOW Reader 300 and Accessories
CYBOW 10 Reagent Strip for Urinalysis (Urobilinogen)
SO 10M
Family Dr. Quick Test Total Cholesterol
HEALTH MATE hCG Combo Plus
MECHATRONICS Starrsed NSTA
RR MECHATRONICS MANUFACTURING B.V.
SHIMADZU Digital Angiography System
SHIMADZU CORPORATION
COMBOSTIK 3 (Protein, pH, Glucose)
DFI CO., LTD.
COMBOSTIK โข R-300 and Accessories
DFI CO., LTD.
BIOGRAM ColorJet Nano
BIO-GRAM DIAGNOSTICS GMBH
COMBOSTIK R-600S and Accessories
DFI CO., LTD.
BIOGRAM JaClean
BIO-GRAM DIAGNOSTICS GMBH
BIOGRAM Safranin-FX JetDye-AF
BIO-GRAM DIAGNOSTICS GMBH
BIOGRAM Lugol's JetDye-AF
BIO-GRAM DIAGNOSTICS GMBH
BIOGRAM JetBuffer pH 6.8
BIO-GRAM DIAGNOSTICS GMBH

