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careGENE™ HPV Screening kit-H - Indonesia BPOM Medical Device Registration

careGENE™ HPV Screening kit-H is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20306320286. The device is manufactured by WELLS BIO, INC. from Korea, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MEDISINDO BAHANA.

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BPOM Registered
Risk Class Kelas Resiko : C
careGENE™ HPV Screening kit-H
Analysis ID: AKL 20306320286

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

WELLS BIO, INC.

Country of Origin

Korea

Authorized Representative

PT. MEDISINDO BAHANA

AR Address

Rukan Graha Cempaka Mas Blok E No.15 Lt.3, Jl. Letjen Suprapto No.1, Jakarta Pusat

Registration Date

Sep 04, 2023

Expiry Date

Jun 22, 2026

Product Type

Tumor Antigen Immunologic Test System

Dna Detection for Human Papillomavirus

Invitro Diagnostics

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