Bio-Vim
by Chetan Meditech Pvt. Ltd. India EUDAMED
Ref 10078Model Bioabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor EMDN H9007
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042103cmplimp001X7 | Date2 Apr 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2024-MDR/QS-031 Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
- 2024-MDR/TD-031 Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
Specification
- Device Name
- BIOTEK, BIO-VIM, BIO-VIM LRP, BIO-VIM LRT, ARTHROVIMS BR Anchor
- Model / Reference
- Bioabsorbable Soft Tissue & Bone Fixation Devices - Bone and Suture Anchor, 10078
- Primary DI / UDI-DI
- 18904210302260
- Basic UDI-DI
- 89042103cmplimp001X7
- EMDN Code
- H9007 ANCHORS FOR SOFT TISSUE SUTURE (excluding P09120102 ANCHORS FOR TENDON-LIGAMENT SYNTHESIS)
- Device Class
- Class III
- Market of Registration
- Austria
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 (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: 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 34f1b3a3-2ec4-4bff-90a0-c3df3f71e044