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SILTEX® Round Gel Breast Implant Cohesive I™ - Indonesia BPOM Medical Device Registration

SILTEX® Round Gel Breast Implant Cohesive I™ is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31603110633. The device is manufactured by MENTOR MEDICAL SYSTEM 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.

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BPOM Registered
Risk Class Kelas Resiko : D
SILTEX® Round Gel Breast Implant Cohesive I™
Analysis ID: AKL 31603110633

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

May 13, 2020

Expiry Date

Jun 27, 2024

Product Type

Prosthetic Surgical Equipment

Silicone gel-filled breast prosthesis.

Non Electromedic Sterile

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