VITROS XT 7600 Integrated System - Indonesia BPOM Medical Device Registration

VITROS XT 7600 Integrated System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20102220248. 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 EMERALINDO ASIA PACIFIC.

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BPOM Registered

Risk Class Kelas Resiko : B

VITROS XT 7600 Integrated System

Analysis ID: AKL 20102220248

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

NPA DE MEXICO S. DE R.L DE C.V

Country of Origin

Mexico

Authorized Representative

EMERALINDO ASIA PACIFIC

AR 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

Jan 25, 2024

Expiry Date

Feb 24, 2028

Product Type

Clinical Laboratory Equipment

Instrumentation for clinical multiplex test systems.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Kelas Resiko : B

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ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : A

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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

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ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B

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ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B

VITROS Immunodiagnostic Products HBeAg Reagent Pack

ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : D

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ORTHO-CLINICAL DIAGNOSTICS

Kelas Resiko : B