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ORAgene -DNA for assisted collection of human DNA - Indonesia BPOM Medical Device Registration

ORAgene -DNA for assisted collection of human DNA is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 10203020153. 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. SCIENCEWERKE.

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BPOM Registered
Risk Class Kelas Resiko : A
ORAgene -DNA for assisted collection of human DNA
Analysis ID: AKL 10203020153

Risk Classification

Kelas Resiko : A

Product Class

Kelas : 1

Manufacturer

DNA GENOTEK INC.

Country of Origin

Canada

Authorized Representative

PT. SCIENCEWERKE

AR Address

Jl.Palmerah Barat No.25

Registration Date

Oct 24, 2022

Expiry Date

Jun 16, 2027

Product Type

Pathology Equipment and Accessories

Specimen transport and storage container.

Invitro Diagnostics

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