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Amielle Comfort - Indonesia BPOM Medical Device Registration

Amielle Comfort is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21102420001. The device is manufactured by OWEN MUMFORD SDN BHD from Malaysia, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is ANDAMAN MEDICAL 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
Amielle Comfort
Analysis ID: AKL 21102420001

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Malaysia

Authorized Representative

ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Jan 29, 2024

Expiry Date

Sep 18, 2028

Product Type

Prosthetic Obstetric and Gynaecological Equipment

Vaginal stent.

Non Electromedic Non Sterile

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