MENTOR SMOOTH Round Gel Breast Implant Family Cohesive I - Indonesia BPOM Medical Device Registration
MENTOR 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 31602320324. 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 AND JOHNSON INDONESIA TWO.
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 AND JOHNSON INDONESIA TWOAR Address
K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A.
Registration Date
May 09, 2024
Expiry Date
Sep 13, 2028
Product Type
Prosthetic Surgical Equipment
Silicone gel-filled breast prosthesis.
Non Electromedic Sterile
MEMORYGEL SILTEX Round Xtra Gel Breast Implant
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 SILTEXโข Round Xtra Gel Breast Implant
SMOOTH Round Gel Breast Implant Family Cohesive Iโข
MEGADYNE Smoke Evacuator
JABIL INC.
Harmonic 1100 Shears
ETHICON ENDO-SURGERY S.A. DE. C.V. PLANTA II
ECHELON FLEX Powered Vascular Stapler
NYPRO HEALTHCARE BAJA INC.
Coated VICRYL RAPIDE (Polyglactin 910) Synthetic Absorbableย Suture
JOHNSON & JOHNSON DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAUDE LTDA.
VICRYL Rapide Polyglactine 910
JOHNSON & JOHNSON MEDICAL GMBH
Coated VICRYL Plus Antibacterial with Irgacare MP (Polyglactin 910) Suture
ETHICON, INC.
VICRYL Plus Antibacterial Polyglactin 910 Absorbable Suture
JOHNSON & JOHNSON MEDICAL GMBH
Coated VICRYL Plus Antibacterial (Polyglactin 910) Suture
ETHICON, INC.
ENDOPATH Ultra Veress Insufflation Needles
HARMAC MEDICAL PRODUCTS, INC.
DEPUY INSTRUMENT (PARAGON CHANGZHOU)
PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD

