ATELLICA ™ IM Anti-Hepatitis B core Total (HBcT) - Indonesia BPOM Medical Device Registration
ATELLICA ™ IM Anti-Hepatitis B core Total (HBcT) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220074. The device is manufactured by SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE) from United States, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS INDONESIA.
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 : 3
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)Country of Origin
United States
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl. Tahi Bonar Simatupang Kav. 88, Kel. Kebagusan, Kec. Pasar Minggu, Jakarta Selatan, DKI Jakarta
Registration Date
Mar 25, 2022
Expiry Date
Mar 04, 2025
Product Type
Immunological Test System
Antimitochondrial antibody immunological test system.
Invitro Diagnostics
ADVIA Centaur CA 15-3
ADVIA Centaur T4 Diluent
ADVIA Centaur Vitamin D Total Quality Control Material
ATELLICA IM Intact Parathyroid Hormone (PTH)
ADVIA Centaur Calibrator G
ADVIA Centaur HBsAgII (HBsII)
ADVIA Centaur Probe Wash 4
ADVIA Centaur NT-proBNP
ADVIA Centaur T3 Diluent
Advia Centaur TnI-Ultra
ADVIA Centaur Calibrator D
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 Systems Allergen Specific IgE Universal Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)
SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)
DIMENSION Bilirubin Calibrator (TBI/DBI CAL)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur CA 15-3
SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)
ADVIA Centaur Insulin (IRI)
MINARIS MEDICAL CO., LTD.
CLINITEK Status+ Analyzer and Accessories
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
DIMENSION Tacrolimus Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS INC.

