VITROS Chemistry Products PHYT Slides - Indonesia BPOM Medical Device Registration

VITROS Chemistry Products PHYT Slides is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103320447. The device is manufactured by ORTHO-CLINICAL DIAGNOSTICS INC., from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is 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.

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BPOM Registered

Risk Class Kelas Resiko : B

VITROS Chemistry Products PHYT Slides

Analysis ID: AKL 20103320447

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS INC.,

Country of Origin

United States

Authorized Representative

EMERALINDO ASIA PACIFIC

AR 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

Jul 11, 2023

Expiry Date

Feb 24, 2028

Product Type

Clinical Toxicology Test System

Diphenylhydantoin test system(card)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Products with the same authorized representative (10 products)

VITROS Chemistry Products wrCRP Reagent

SENTINEL DIAGNOSTICS

Kelas Resiko : B

VITROS Immunodiagnostic Products System Cleaning Solution

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : A

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : D

VITROS Immunodiagnostic Products Rubella IgM Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : C

VITROS Immunodiagnostic Products Rubella IgM Calibrator

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : C

VITROS Immunodiagnostic Products Free PSA Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : C

VITROS Immunodiagnostic Products Total T3 Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B

VITROS Immunodiagnostic Products LH Calibrators

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B

VITROS Immunodiagnostic Products HBeAg Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : D

VITROS Immunodiagnostic Products Testosterone Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B