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Fiberknot
EUDAMEDClass IIb (EU MDR)
Ref 10028Model Nonabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor
Identity
- Trade Name
- FIBERKNOT EUDAMED
- Device Name
- BIOTEK, MICRO-VIM, MINI-VIM, SUPER-VIM, SUPER-VIM III, SUPER-VIM L, MICRO-VIM PK, MINI-VIM PK, MINI-VIM II PK, VIMFIX-PK, VIMFIX-PK III, VIMFIX-LRP, VIMFIX- LRT, VIMFIX-BT, FIBERKNOT EUDAMED
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor EUDAMED10028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904210301454 EUDAMED
- Basic UDI-DI
- 89042103cmplimp002X9 EUDAMED
- EMDN Code
- H9007,P09120102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
No
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
Fiberknot 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 | 89042103cmplimp002X9 | 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 62444658-7660-41c3-a93f-e8c26fa2c287 61 fields · synced Jun 18, 2026