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GEL MARK ULTRA Breast Tissue Marker - Indonesia BPOM Medical Device Registration

GEL MARK ULTRA Breast Tissue Marker is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21603021929. The device is manufactured by MEDICAL INFUSION (THAILAND) CO., LTD. from Thailand, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PRO-HEALTH INTERNATIONAL.

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 : C
GEL MARK ULTRA Breast Tissue Marker
Analysis ID: AKL 21603021929

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Thailand

Authorized Representative

PRO-HEALTH INTERNATIONAL

AR Address

Komplek Perkantoran Duta Merlin Blok C 35-36 Jalan Gajah Mada 3-5

Registration Date

May 27, 2022

Expiry Date

Feb 08, 2027

Product Type

Surgical Equipment

Implantable Clip

Non Electromedic Sterile

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