Chord-X® Pre-Measured Loops, 16mm loop (3/8 circle)
Ref CXL-20-1838-16Model CXL-20-1812-0
Active
CE MDR
Valid until
30 Jan 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR 781097 | Date31 Aug 2026 | StatusActive |
Certificates
- MDR 781097 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 31 Aug 2026
- Expires
- 30 Jan 2030
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Chord-X Suture System
- Model / Reference
- CXL-20-1812-0, CXL-20-1838-16
- Primary DI / UDI-DI
- 00813570020671
- Basic UDI-DI
- 81357002CXLVB
- Unit of Use DI
- 00813570020275
- EMDN Code
- P07038004 Heart valve reconstruction implants
- Device Class
- Class III
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- US-MF-000015763
- Authorised representative
- JOTEC GmbH DE-AR-000006801
Other devices from Artivion, Inc.
Properties
Other properties (9)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No