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SMARTCARE Disposable Vaginal Speculum - Indonesia BPOM Medical Device Registration

SMARTCARE Disposable Vaginal Speculum is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21103420106. The device is manufactured by CHANGZHOU SHUANGMA MEDICAL DEVICES CO.,LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SMART CARE INDONESIA.

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
SMARTCARE Disposable Vaginal Speculum
Analysis ID: AKL 21103420106

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. SMART CARE INDONESIA

AR Address

VILLA(RUKO ) MELATI MAS SQUARE BLOK A.3 NO. 8, JELUPANG, SERPONG UTARA,TANGERANG SELATAN

Registration Date

Mar 04, 2024

Expiry Date

Jan 03, 2027

Product Type

Surgical Obstetric and Gynaecological Equipment

Obstetric-gynecologic specialized manual instrument.

Non Electromedic Sterile

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