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ESIGHT HCG Pregnancy Test - Indonesia BPOM Medical Device Registration

ESIGHT HCG Pregnancy Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101322977. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD., CHINA from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SARANA KARYA MEDIKA.

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
ESIGHT HCG Pregnancy Test
Analysis ID: AKL 20101322977

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. SARANA KARYA MEDIKA

AR Address

UBUD VILLAGE BLOK KINTAMANI C1 NO.15 KEL.SUDIMARA TIMUR

Registration Date

Apr 26, 2023

Expiry Date

Feb 01, 2027

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system (strip & midstream)

Invitro Diagnostics

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