ORTHO Workstation BioVue - Indonesia BPOM Medical Device Registration
ORTHO Workstation BioVue is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20209022159. The device is manufactured by MACK MOLDING COMPANY 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
MACK MOLDING COMPANYCountry of Origin
United States
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 01, 2024
Expiry Date
Feb 24, 2028
Product Type
Products used in the manufacture of blood preparations and preparations of origin and blood
Automated cell-washing centrifuge for immuno-hematology.
Invitro Diagnostics
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

