Pure Global

COULTER CLONE T8-RD1 - Indonesia BPOM Medical Device Registration

COULTER CLONE T8-RD1 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205420132. The device is manufactured by BECKMAN COULTER, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FOCUS DIAGNOSTIC INDONESIA.

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
COULTER CLONE T8-RD1
Analysis ID: AKL 20205420132

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. FOCUS DIAGNOSTIC INDONESIA

AR Address

Jl. Jatipadang Raya No.9A, RT.6/RW.4, Kelurahan Jatipadang, Kecamatan Pasar Minggu, Kota Jakarta Selatan, DKI Jakarta 12540

Registration Date

Aug 04, 2024

Expiry Date

Dec 31, 2027

Product Type

Automatic and Semi-Automatic Hematology Equipment

Automated differential cell counter.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing