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BioFix-NP
EUDAMEDClass IIb (EU MDR)
Ref 10162Model Nonabsorbable Soft Tissue & Bone Fixation Device - Bone Fixation Plates and WasherRef 10163
Identity
- Trade Name
- BioFix-NP EUDAMED
- Device Name
- BIOTEK, BioFix-NP, BioFix-DF, BioFix EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Bone Fixation Plates and Washer EUDAMED10162 EUDAMED10163 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210302543 EUDAMED18904210302550 EUDAMED
- Basic UDI-DI
- 89042103cmplimp003XB EUDAMED
- EMDN Code
- P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMEDPoland 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-NP 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 |
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Manufacturer
- Manufacturer
- Chetan Meditech Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000013541
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 1db8c532-61b1-4db8-acc5-44976da6c63c 61 fields · synced Jul 30, 2026
- EUDAMED e2320cca-5fe8-4c1d-89a9-50794b6f363f 61 fields · synced Jul 30, 2026