VITROS 3600 Immunodiagnostic System - Indonesia BPOM Medical Device Registration
VITROS 3600 Immunodiagnostic System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102025933. The device is manufactured by NPA DE MEXICO S. DE R.L DE C.V. from Mexico, and is classified as Risk Class Kelas Resiko : B. 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
NPA DE MEXICO S. DE R.L DE C.V.Country of Origin
Mexico
Authorized Representative
PT. EMERALINDO ASIA PACIFICAR Address
RUKAN PERMATA SENAYAN BLOK G15, Lantai 1, JL.TENTARA PELAJAR NO. 5, Desa/Kelurahan Grogol Utara, Kec. Kebayoran Lama, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta Kode Pos: 12210
Registration Date
Feb 11, 2025
Expiry Date
Feb 24, 2028
Product Type
Clinical Laboratory Equipment
Instrumentation for clinical multiplex test systems.
Invitro Diagnostics
VITROS 5600 Integrated System and Accessories
HARMONIC ACE +7 Shears with Advanced Hemostasis
LIGAMAX 5mm Endoscopic Multiple Clip Applier
HARMONIC Gray Hand Piece
HARMONIC Blue Hand Piece
HARMONIC HD1000i Shears
HARMONIC 1100 Shears
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 Chemistry Products Maintenance Pack
ORTHO-CLINICAL DIAGNOSTICS
VITROS Immunodiagnostic Products Toxoplasma IgM Reagent 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
VITROS Immunodiagnostic Products Anti-HAV Total Calibrator
ORTHO-CLINICAL DIAGNOSTICS