SROM NOILES - Indonesia BPOM Medical Device Registration
SROM NOILES is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320694. The device is manufactured by DEPUY ORTHOPAEDICS INC. from United States, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. JOHNSON AND JOHNSON INDONESIA TWO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
DEPUY ORTHOPAEDICS INC.Country of Origin
United States
Authorized Representative
PT. JOHNSON AND JOHNSON INDONESIA TWOAR Address
K-Link Tower, Lt. 15, Jl. Jend. Gatot Subroto kav. 59A, Kuningan, Setiabudi, Jakarta Selatan, Desa/Kelurahan Kuningan Timur, Kec. Setiabudi, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta, Kode Pos: 12950
Registration Date
May 30, 2023
Expiry Date
Feb 21, 2028
Product Type
Prosthetic Orthopedic Equipment
Knee joint femorotibial metal/polymer constrained cemented prosthesis.
Non Electromedic Sterile
DEPUY Instrument (DEPUY ORTHOPAEDICS INC. USA)
PINNACLE GRIPTION Acetabular Shell
SIGMA Knee System
ARTICUL/EZE Femoral Head
SOLUTION SYSTEM
PINNACLE Cancellous Bone Screw
PINNACLE MARATHON Polyethylene Acetabular Liner
DEPUY Titanium Roof Pile Screw
DEPUY Modular Endo Heads
SUMMIT Tapered Hip System
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 Absorbable 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