← Back to catalogue
BioFix-DF
EUDAMEDClass IIb (EU MDR)
Ref 10407Model Nonabsorbable Soft Tissue & Bone Fixation Device - Bone Fixation Plates and Washer
Identity
- Trade Name
- BioFix-DF EUDAMED
- Device Name
- BIOTEK, BioFix-NP, BioFix-DF, BioFix EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Bone Fixation Plates and Washer EUDAMED10407 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210305469 EUDAMED
- Basic UDI-DI
- 89042103cmplimp003XB EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
BioFix-DF by Chetan Meditech Pvt. Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 89042103cmplimp003XB | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chetan Meditech Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000013541
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED a6b80fe4-2126-4c70-ae7a-7245225a8338 61 fields · synced Jul 21, 2026