ATELLICA IM Squamous Cell Carcinoma (SCC) - Indonesia BPOM Medical Device Registration
ATELLICA IM Squamous Cell Carcinoma (SCC) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320254. The device is manufactured by FUJIREBIO EUROPE N.V. from Belgium, and is classified as Risk Class Kelas Resiko : B. 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 : 2
Manufacturer
FUJIREBIO EUROPE N.V.Country of Origin
Belgium
Authorized Representative
PT. SIEMENS HEALTHINEERS INDONESIAAR Address
Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88
Registration Date
Jul 25, 2023
Expiry Date
Mar 04, 2025
Product Type
Tumor Antigen Immunologic Test System
Immunomagnetic circulating cancer cell selection and enumeration system.
Invitro Diagnostics
INNO-LiPA HPV Genotyping Extra II Amp <20T, CE>
INNO-LiPA HPV Genotyping Extra II <20T,CE>
INNO-LIA HIV I/II Score
INNOTEST ฮฒ-AMYLOID(1-40)
INNOTEST PHOSPHO-TAU (181P)
INNO-LIA HCV Score
INNOTEST ฮฒ-AMYLOID(1-42)
INNOTEST hTau Ag
Tendigo
LiRAS for LiPA HPV v3
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.