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DIRECTCHECK Whole Blood Controls - Indonesia BPOM Medical Device Registration

DIRECTCHECK Whole Blood Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20205811590. The device is manufactured by ACCRIVA DIAGNOSTICS, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DEMKA SAKTI.

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
DIRECTCHECK Whole Blood Controls
Analysis ID: AKL 20205811590

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. DEMKA SAKTI

AR Address

JLN. TANAH ABANG III/19 A-B, RT.002/RW.003

Registration Date

Nov 11, 2024

Expiry Date

Dec 31, 2028

Product Type

Automatic and Semi-Automatic Hematology Equipment

Multipurpose system for in vitro coagulation studies

Invitro Diagnostics

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