Pure Global

MEMORYGEL SILTEX™ Round Xtra Gel Breast Implant - Indonesia BPOM Medical Device Registration

MEMORYGEL SILTEX™ Round Xtra Gel Breast Implant is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31602023270. The device is manufactured by MENTOR MEDICAL SYSTEMS B.V. from Netherlands, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. JOHNSON & JOHNSON NEW ZEALAND.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : D
MEMORYGEL SILTEX™ Round Xtra Gel Breast Implant
Analysis ID: AKL 31602023270

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

Netherlands

Authorized Representative

PT. JOHNSON & JOHNSON NEW ZEALAND

AR Address

K-Link Tower Lt. 12, Jln. Jend. Gatot Subroto Kav. 59 A

Registration Date

Jun 16, 2020

Expiry Date

Jun 27, 2024

Product Type

Prosthetic Surgical Equipment

Silicone gel-filled breast prosthesis.

Non Electromedic Sterile

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing