EUROLINE Autoimmune Liver Diseases (IgG) - Indonesia BPOM Medical Device Registration
EUROLINE Autoimmune Liver Diseases (IgG) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305718345. The device is manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INTI MAKMUR MEDITAMA.
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
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.Country of Origin
Germany
Authorized Representative
PT. INTI MAKMUR MEDITAMAAR Address
Gandaria 8 Office Tower Lantai 16 Unit F Jl. Sultan Iskandar Muda No. 8 RT 010 RW 006
Registration Date
Jan 09, 2025
Expiry Date
Aug 30, 2028
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
Invitro Diagnostics
EUROIMMUN IIFT Mosaic: Kidney (Rat) / Stomach ( Rat )
EUROIMMUN EUROStar III Plus Microscope
EUROIMMUN 25-OH Vitamin D ELISA
EUROLINE Coeliac Disease Profile (IgA)
EUROIMMUN Anti-Rubella Virus ELISA (IgG)
EUROLINE Systemic sclerosis (Nucleoli) profile (IgG)
EUROIMMUN ANA Screen ELISA (IgG)
EUROIMMUN Anti-Aquaporin-4 IIFT
EUROIMMUN Anti-Mycoplasma Pneumoniae Elisa (IgG)
EUROIMMUN Anti-Mycoplasma Pneumoniae ELISA (IgM)
EUROIMMUN IIFT Mosaic: Kidney (Rat) / Stomach ( Rat )
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.
EUROIMMUN EUROStar III Plus Microscope
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.
EUROIMMUN Leptin ELISA
DIAGNOSTICS BIOCHEM CANADA INC.
EUROIMMUN 25-OH Vitamin D ELISA
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.
EUROIMMUN IF Sprinter and Accessories
G.S.G. ROBOTIX S.R.L.
EUROIMMUN Anti-Rubella Virus ELISA (IgG)
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.
EUROLINE Coeliac Disease Profile (IgA)
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.
EUROLINE Systemic sclerosis (Nucleoli) profile (IgG)
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.
EUROIMMUN Anti-Aquaporin-4 IIFT
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.
EUROIMMUN ANA Screen ELISA (IgG)
EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG.

