CENTUS Diluent (H-D01) - Indonesia BPOM Medical Device Registration

CENTUS Diluent (H-D01) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20208917638. 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.

Free Database

Powered by Pure Global AI

BPOM Registered

Risk Class Kelas Resiko : B

CENTUS Diluent (H-D01)

Analysis ID: AKL 20208917638

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

Registration Date

Nov 29, 2019

Expiry Date

Mar 31, 2024

Product Type

Hematological Reagents

Blood cell diluents

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

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

Products from the same manufacturer (3 products)

CENTUS Cleaner (H-C01)

Kelas Resiko : A

CENTUS Lyse (H-L01)

Kelas Resiko : B

CENTUS 3-Part Auto Hematology Analyzer

Kelas Resiko : B

Other Products from PT. MACROCITRA ARDANASEJATI

Products with the same authorized representative (10 products)

RIGHTSIGN COC Rapid Test Strip (Urine) 300ng/mL

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : B

RIGHTSIGN COC Rapid Test Cassette (Urine) 300 ng/mL

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : B

RIGHTSIGN BZO Rapid Test Cassette (Urine) 300 ng/ml

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : B

RIGHTSIGN Typhoid Rapid Test Cassette (Serum/Plasma)

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : B

RIGHTSIGN HAV Rapid Test Cassette (Serum/Plasma)

HANGZHOU BIOTEST BIOTECH, CO., LTD.

Kelas Resiko : B

RIGHTSIGN HCV Rapid Test Cassette (Serum/Plasma)

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : D

RIGHTSIGN HBsAg Rapid Test Cassette (Serum/Plasma)

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : D

RIGHTSIGN AMP Rapid Test Strip (Urine)

HANGZHOU BIOTEST BIOTECH CO., LTD

Kelas Resiko : B

RIGHTSIGN AMP Rapid Test Cassette (Urine)

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : B

RIGHTSIGN THC Rapid Test Strip (Urine)

HANGZHOU BIOTEST BIOTECH CO., LTD.

Kelas Resiko : B