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BioFiber
EUDAMEDClass IIb (EU MDR)
Ref BF-2WCModel Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and Tapes
Identity
- Trade Name
- BioFiber EUDAMED
- Device Name
- BIOTEK, BioFiber EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and Tapes EUDAMEDBF-2WC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210300549 EUDAMED
- Basic UDI-DI
- 89042103cmplimp007XK EUDAMED
- EMDN Code
- H0102010299 SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece 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
BioFiber 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 | 89042103cmplimp007XK | 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 (1)
- EUDAMED 7deea784-c045-4c5f-89ba-f23bd5966260 61 fields · synced Jun 11, 2026