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IOTest CD8-PE - Indonesia BPOM Medical Device Registration

IOTest CD8-PE is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205420052. The device is manufactured by IMMUNOTECH S.A.S., A BECKMAN COULTER COMPANY from France, 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.

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BPOM Registered
Risk Class Kelas Resiko : B
IOTest CD8-PE
Analysis ID: AKL 20205420052

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

France

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

Mar 19, 2024

Expiry Date

Dec 31, 2027

Product Type

Automatic and Semi-Automatic Hematology Equipment

Automated differential cell counter

Invitro Diagnostics

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