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OVUTEST Fertility Test Strips - Indonesia BPOM Medical Device Registration

OVUTEST Fertility Test Strips is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101912835. The device is manufactured by SHENZHEN GLD BIOTECHNOLOGY LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. DANPAC PHARMA.

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
OVUTEST Fertility Test Strips

OVUTEST Strip Uji Kesuburan

Analysis ID: AKL 20101912835

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. DANPAC PHARMA

AR Address

Green Sedayu Biz Park, Blok DM5, No. 31E, Jl. Daan Mogot, KM 18, RT.11/RW.6, Kelurahan Kalideres, Kecamatan Kalideres, Kota Jakarta Barat, Daerah Khusus Ibukota Jakarta 11840

Registration Date

Dec 30, 2024

Expiry Date

Jun 21, 2026

Product Type

Clinical Chemistry Test System

Luteinizing hormone test system (strip & midstream)

Invitro Diagnostics

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