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BioFiber
EUDAMEDClass IIb (EU MDR)
Ref 10068Model Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and TapesRef 10206Ref 10688Ref 10390Ref 10207Ref 10090Ref 10220Ref BF-2WNCRef 10508Ref 10127Ref BF-5WKRef 10291Ref 10126Ref BF-4IN1.S2Ref BF-2WSBRef BF-16BSTRef BF-WWBRef 10389Ref 10509Ref 10091
Identity
- Trade Name
- BioFiber EUDAMED
- Device Name
- BIOTEK, BioFiber EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Sutures and Tapes EUDAMED10068 EUDAMED10206 EUDAMED10688 EUDAMED10390 EUDAMED10207 EUDAMED10090 EUDAMED10220 EUDAMEDBF-2WNC EUDAMED10508 EUDAMED10127 EUDAMEDBF-5WK EUDAMED10291 EUDAMED10126 EUDAMEDBF-4IN1.S2 EUDAMEDBF-2WSB EUDAMEDBF-16BST EUDAMEDBF-WWB EUDAMED10389 EUDAMED10509 EUDAMED10091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210302215 EUDAMED18904210304486 EUDAMED18904210307609 EUDAMED18904210305308 EUDAMED18904210304493 EUDAMED18904210302314 EUDAMED18904210304882 EUDAMED18904210301133 EUDAMED18904210306206 EUDAMED18904210302482 EUDAMED18904210300853 EUDAMED18904210304912 EUDAMED18904210302475 EUDAMED18904210301348 EUDAMED18904210301126 EUDAMED18904210301331 EUDAMED18904210301386 EUDAMED18904210305292 EUDAMED18904210306213 EUDAMED18904210302321 EUDAMED
- Basic UDI-DI
- 89042103cmplimp007XK EUDAMED
- EMDN Code
- H0102010299 SYNTHETIC NONABSORBABLE MULTIFILAMENT SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMEDGreece 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
Category: Polyester suture, non-bioabsorbable, multifilament
BioFiber by Chetan Meditech Pvt. Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (20)
- EUDAMED 0a055825-f203-48dd-8b80-7c8f8b3d4c27 61 fields · synced Sep 17, 2026
- EUDAMED bd5afe69-10b4-4cfb-babc-ce282d0232cd 61 fields · synced May 17, 2026
- EUDAMED abc85e19-ada5-4171-b5cc-ce4d17a414fd 61 fields · synced Jul 9, 2026
- EUDAMED 6a9791a2-d7f6-438a-9539-fcfcc1a42e14 61 fields · synced Jul 9, 2026
- EUDAMED d52b6655-d92b-409e-bb10-389e948c9625 61 fields · synced Jul 9, 2026
- EUDAMED 5be50130-e96b-4432-9f8c-a0b64c601416 61 fields · synced Jul 9, 2026
- EUDAMED 41e6368d-533b-4def-a44c-e2cfd7ab23b0 61 fields · synced Jul 9, 2026
- EUDAMED 9658dc9a-cfbe-41c0-8175-ef1f3f81d0b8 61 fields · synced Jul 9, 2026
- EUDAMED df37e270-c4af-4e9b-8e41-6f4114860fc3 61 fields · synced Jul 11, 2026
- EUDAMED 87a1d732-c0c0-451f-9bf8-86cac6f1891e 61 fields · synced Jul 12, 2026
- EUDAMED e03d4af7-6352-439d-96b9-043f4a8417a1 61 fields · synced Jul 14, 2026
- EUDAMED 76cb5e1a-0ccd-4749-b399-038548b89397 61 fields · synced Jul 14, 2026
- EUDAMED 00935622-bdf9-4d5a-a13d-fafdbac3c2b7 61 fields · synced Jul 17, 2026
- EUDAMED 76de24b3-da2b-4473-9b1c-fd889cada249 61 fields · synced Jul 22, 2026
- EUDAMED fe0d5b8e-6a0f-4779-aa90-9b1d9f3a5bb3 61 fields · synced Jul 22, 2026
- EUDAMED 176d2f87-3963-460a-ac38-cba023f507bb 61 fields · synced Jul 25, 2026
- EUDAMED c9454f49-65a5-4178-8026-f4bab3700d2e 61 fields · synced Jul 29, 2026
- EUDAMED 2a37e201-81a4-4169-8f97-e9de96deb8bf 61 fields · synced Aug 2, 2026
- EUDAMED ab10720a-5e92-40f8-8bbf-e1848230ad95 61 fields · synced Sep 17, 2026
- EUDAMED d5e1028d-f19e-4ac5-8f25-c38e1224c9ac 61 fields · synced Sep 17, 2026