OSTHYONE Metal Bone Screws - Indonesia BPOM Medical Device Registration
OSTHYONE Metal Bone Screws is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21302320659. The device is manufactured by CANWELL MEDICAL CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAGNIFICENT DINAR CALAKAN.
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
CANWELL MEDICAL CO., LTD.Country of Origin
China
Authorized Representative
PT. MAGNIFICENT DINAR CALAKANAR Address
Citra Swarna Regency, Jalan Melati Raya Barat
Registration Date
May 10, 2023
Expiry Date
May 04, 2026
Product Type
Prosthetic Orthopedic Equipment
Single/multiple component metallic bone fixation appliances and accessories.
Non Electromedic Non Sterile
SMITH & NEPHEW ANTHEM Total Knee System Instruments
CANWELL Lateral Lumbar Interbody Fusion System CanPEEK-L Instrument Set
CANWELL Spinal Fixation Device
OSTHYONE Metal Bone Screws II
OSTHYONE Metal Bone Plates II
OSTHYONE Metal Bone Plates III
OSTHYONE Intramedullary Nails Systems
OSTHYONE Metal Bone Plates
CANWELL MEDICAL Anterior Cervical Cage System CanPEEK-C
CANWELL MEDICAL Transforminal Lumbar Interbody Fusion System CanPEEK-T
OSTHYONE Metal Bone Plate 4
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
OSTHYONE Intramedullary Nails Systems
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
OSTHYONE Medical Electric Drill – Acetabular Reaming Drill RJ-PD
WUHU RUIJIN MEDICAL INSTRUMENT & DEVICE CO.,LTD
SAC Single Use Sterile Suction Assisted Closure Dressing Kit
SAC (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
ALCASIS Genta Bone Cement With Antibiotic
TABIB FARMA PHARMACEUTICALS MEDICAL DEVICES MEDICAL ORTHOPEDICS FOOD AGRICULTURE VEGETABLE OILS PRODUCTION CONSTRUCTION AND CONSTRUCTION MATERIALS INDUSTRY AND TRADE LTD. STI.
SAC Negative Pressure Wound Therapy System
SAC (XIAMEN) MEDICAL TECHNOLOGY CO., LTD.
OSTHYONE Metal Bone Screws 3
TIANJIN WALKMAN BIOMATERIAL CO.,LTD
OSTHYONE Medical Electric Saw – Oscillating Saw RJ-PS (NS-1511)
WUHU RUIJIN MEDICAL INSTRUMENT & DEVICE CO.,LTD
OSTHYONE Metal Bone Screws 2
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
OSTHYONE Metal Bone Screws
TIANJIN WALKMAN BIOMATERIAL CO., LTD.