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ACUVU HTx Disposable Hysteroscope - Indonesia BPOM Medical Device Registration

ACUVU HTx Disposable Hysteroscope is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21106420027. The device is manufactured by ACUVU MEDICAL TECHNOLOGY (CHANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PRIMA HEALTH CARE.

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
ACUVU HTx Disposable Hysteroscope
Analysis ID: AKL 21106420027

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. PRIMA HEALTH CARE

AR Address

Green Sedayu Biz Park Jl. Daan Mogot Km. 18 Blok DM 16 No. 79

Registration Date

May 25, 2024

Expiry Date

Aug 14, 2026

Product Type

Diagnostic Obstetric and Gynaecological Equipment

Hysteroscope and accessories.

Non Electromedic Sterile

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