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LensHooke Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) - Indonesia BPOM Medical Device Registration

LensHooke Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305420578. The device is manufactured by BONRAYBIO CO., LTD. from Taiwan (China), and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SONNA MEDIKA JAYA.

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
LensHooke Sperm DNA Fragmentation Rapid Test Kit (SCD Assay)
Analysis ID: AKL 20305420578

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Taiwan (China)

Authorized Representative

PT. SONNA MEDIKA JAYA

AR Address

Rukan Sentra Niaga Blok M, Green Lake City, No.017 RT. 007 RW.008, Duri Kosambi, Cengkareng, Jakarta Barat

Registration Date

Nov 19, 2024

Expiry Date

May 13, 2029

Product Type

Immunological Test System

Seminal fluid (sperm) immunological test system.

Invitro Diagnostics

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DJ Fang

DJ Fang

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