Biocinch-AI2
by Chetan Meditech Pvt. Ltd. 8 variants
Ref 10472Model Nonabsorbable Soft Tissue & Bone Fixation Device - Meniscal Repair Devices
Active
CE MDR
Valid until
7 Jan 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number89042103cmplimp005XF 18904210306053 | Date8 Apr 2025 | StatusActive |
Certificates
- 2024-MDR/QS-034 Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 1 Jul 2024
- Expires
- 1 Jul 2029
- 2024-MDR/TD-034 Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 7 Jan 2024
- Expires
- 7 Jan 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Biotek, Biocinch, Biocinch-AI2
- Model / Reference
- Nonabsorbable Soft Tissue & Bone Fixation Device - Meniscal Repair Devices, 10472
- Primary DI / UDI-DI
- 18904210306053
- Basic UDI-DI
- 89042103cmplimp005XF
- EMDN Code
- H9007, P09120102
- Device Class
- Class IIb
- Market of Registration
- Sweden
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
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