FIXAMET Hip Joint Prostheses - Indonesia BPOM Medical Device Registration
FIXAMET Hip Joint Prostheses is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302420008. The device is manufactured by SHENZHEN BONE MEDICAL DEVICES CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. FIXA MEDIKA TAMA.
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 : 2
Manufacturer
SHENZHEN BONE MEDICAL DEVICES CO., LTD.Country of Origin
China
Authorized Representative
PT. FIXA MEDIKA TAMAAR Address
RUKAN ROSES GARDEN 5, BLOK RRG N0. 50, GRAND GALAXY CITY
Registration Date
Jan 11, 2024
Expiry Date
Nov 08, 2026
Product Type
Prosthetic Orthopedic Equipment
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Non Electromedic Sterile
OSTEOPRIME Hip Prostheses
OSTEOPRIME Knee Prostheses
OSTHYONE Hip Arthroplasty Instrument
OSTHYONE Knee Arthroplasty Instrument
OSTHYONE Bone Cement Casing Components (Bone Cement Syringe)
OSTHYONE Hip Prostheses
OSTHYONE Knee Prostheses
FIXAMET Knee Arthroplasty Device Set
FIXAMET Knee Prostheses
KAUSHIK Bone Plates and Screws
KAUSHIK ORTHOPAEDIC PVT. LTD.
ZIMED Bone Plate and Screw Systems
ZIMED MEDIKAL SAN. VE TIC. LTD. STI.
FIXAMET Knee Arthroplasty Device Set
SHENZHEN BONE MEDICAL DEVICES CO., LTD.
ZIMED Intramedullary Nail Systems
ZIMED MEDIKAL SAN. VE TIC. LTD. STI.
FIXAMET Knee Prostheses
SHENZHEN BONE MEDICAL DEVICES CO., LTD.
CANWELL MEDICAL CanTSP5.5 Instruments Set
CANWELL MEDICAL CO., LTD.
CANWELL MEDICAL Posterior Lumbar Interbody Fusion System CanPEEK-P
CANWELL MEDICAL CO., LTD.
CANWELL MEDICAL Mini Fragment Plating Instrument Set
CANWELL MEDICAL CO., LTD.
CANWELL MEDICAL Intramedullary Nail
CANWELL MEDICAL CO., LTD.
CANWELL MEDICAL Bone Screws
CANWELL MEDICAL CO., LTD.