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ORACollect DNA (OCR-100) - Indonesia BPOM Medical Device Registration

ORACollect DNA (OCR-100) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10203220133. The device is manufactured by DNA GENOTEK INC. from Canada, and is classified as Risk Class Kelas Resiko : A. The authorized representative in Indonesia is PT. CULTURO INTEGRA NIAGA.

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 : A
ORACollect DNA (OCR-100)
Analysis ID: AKL 10203220133

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Manufacturer

DNA GENOTEK INC.

Country of Origin

Canada

Authorized Representative

PT. CULTURO INTEGRA NIAGA

AR Address

Kawasan Mega Kuningan, Jl. Dr. Ide Anak Agung Gede Agung No.1 CoHive 101

Registration Date

Dec 07, 2022

Expiry Date

Nov 21, 2027

Product Type

Pathology Equipment and Accessories

Specimen transport and storage container.

Invitro Diagnostics

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