SMOOTH Round Gel Breast Implant Family Cohesive I™ - Indonesia BPOM Medical Device Registration
SMOOTH Round Gel Breast Implant Family Cohesive I™ is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 31603110419. 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.
Risk Classification
Product Class
Kelas : 3
Manufacturer
MENTOR MEDICAL SYSTEMS B.V.Country of Origin
Netherlands
Authorized Representative
PT. JOHNSON & JOHNSON NEW ZEALANDAR Address
K-Link Tower Lt. 12, Jln. Jend. Gatot Subroto Kav. 59 A
Registration Date
May 11, 2020
Expiry Date
Jun 27, 2024
Product Type
Prosthetic Surgical Equipment
Silicone gel-filled breast prosthesis.
Non Electromedic Sterile
MEMORYGEL SILTEX Round Xtra Gel Breast Implant
MENTOR SMOOTH Round Gel Breast Implant Family Cohesive I
MENTOR CPG Sterile Resterilizable Gel Breast Implant Sizer
MENTOR Round Profile Resterilizable Gel Breast Implant Sizer
MEMORYGEL Smooth Round Xtra Gel Breast Implant
MENTOR SILTEX Round Gel Breast Implant Cohesive I
MENTOR CPG Gel Breast Implant Cohesive III
MENTOR Round Low Profile Resterilizable Gel Breast Implan
MEMORYGEL SILTEX™ Round Xtra Gel Breast Implant
PDS PLUS Antibacterial (Polydioxanone) Suture
ETHICON INC.
ETHIBOND EXCEL Coated Polyester
ETHICON, INC.
PROLENE Polypropylene Suture
ETHICON, INC
STRATAFIX Spiral PGA-PCL Knotless Tissue Control Device (Bi-Directional)
SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.
STRATAFIX Spiral PDO Knotless Tissue Control Device (Bi-Directional)
SURGICAL SPECIALTIES MEXICO, S. DE R.L. DE C.V.
DERMABOND* Propen Topical Skin Adhesive
ETHICON LLC.
CARTO VIZIGO BI-DIRECTIONAL GUIDING SHEATH
FREUDENBERG MEDICAL LLC.
DERMABOND PRINEO Skin Closure System
ETHICON LLC.
PROLENE Polypropylene Monofilament Non-Absorbable Suture
ETHICON INC.
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device
ETHICON INC.