CENTUS Lyse (H-L01) - Indonesia BPOM Medical Device Registration

CENTUS Lyse (H-L01) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208916812. The device is manufactured by T&D DIAGNOSTICS CANADA PVT. LTD. from Canada, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MACROCITRA ARDANASEJATI.

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

CENTUS Lyse (H-L01)

Analysis ID: AKL 20208916812

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

T&D DIAGNOSTICS CANADA PVT. LTD.

Country of Origin

Canada

Authorized Representative

PT. MACROCITRA ARDANASEJATI

AR Address

Rukan Taman Meruya Blok M-65 Meruya Ilir - Jakarta Barat Telp. 021-5874575, Fax. 021-5874573

Registration Date

Oct 21, 2019

Expiry Date

Mar 31, 2024

Product Type

Hematological Reagents

Red cell lysing reagent.

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

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Other Products from T&D DIAGNOSTICS CANADA PVT. LTD.

Products from the same manufacturer (3 products)

CENTUS Diluent (H-D01)

Kelas Resiko : B

CENTUS Cleaner (H-C01)

Kelas Resiko : A

CENTUS 3-Part Auto Hematology Analyzer

Kelas Resiko : B

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