AFFIRMAGEN - Indonesia BPOM Medical Device Registration
AFFIRMAGEN is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209021591. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS, INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. EMERALINDO ASIA PACIFIC.
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
ORTHO-CLINICAL DIAGNOSTICS, INC.Country of Origin
United States
Authorized Representative
PT. EMERALINDO ASIA PACIFICAR Address
Rukan Permata Senayan Blok G 15, Jl. Tentara Pelajar Rt/Rw 009/007, Kel. Grogol Utara Kec. Kebayoran Lama, Jakarta Selatan 12210
Registration Date
Sep 19, 2022
Expiry Date
Jun 21, 2024
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Automated blood grouping and antibody test system.
Invitro Diagnostics
VITROS Chemistry Products dLDL Reagent
VITROS Chemistry Products CRP Performance Verifier II
VITROS Chemistry Products CRP Performance Verifier I
VITROS Chemistry Products CRP slides
VITROS Chemistry Products PHOS Slides
VITROS Chemistry Products Specialty Diluent
VITROS Chemistry Products TBIL Slides
VITROS Chemistry Products Isoenzyme Performance Verifier I
VITROS Chemistry Products ACET Slides
VITROS Chemistry Products ECO2 Slides
VITROS 3600 Immunodiagnostic System
NPA DE MEXICO S. DE R.L DE C.V.
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Chemistry Products Calibrator Kit 34
SENTINEL DIAGNOSTICS
VITROS Immunodiagnostic Products Free PSA Calibrators
ORTHO-CLINICAL DIAGNOSTICS
VITROS XT 3400 Chemistry System and Accessories
NPA DE MEXICO S. DE R.L DE C.V
VITROS Immunodiagnostic Products Toxoplasma IgM Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Chemistry Products Maintenance Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products CMV IgM Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Anti-HBc IgM Control
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Rubella IgG Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS