Fiberknot
by Chetan Meditech Pvt. Ltd. India EUDAMED
Ref 10673Model Nonabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor
EMDN H9007
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042103cmplimp002X9 | Date8 Apr 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2024-MDR/QS-032 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
- 2024-MDR/TD-032 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
Specification
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor, 10673
- Primary DI / UDI-DI
- 18904210307555
- Basic UDI-DI
- 89042103cmplimp002X9
- EMDN Code
- H9007 ANCHORS FOR SOFT TISSUE SUTURE (excluding P09120102 ANCHORS FOR TENDON-LIGAMENT SYNTHESIS)
- Device Class
- Class IIb
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- IN-MF-000013541
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Chetan Meditech Pvt. Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Sutures: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED bdbd37a7-865c-4e55-958c-85949eb3ea0c