Dafodil™
by Meril Life Sciences Pvt. Ltd. India EUDAMED
Ref DDL33M
EMDN P070301010202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number1434-MDR-021/2025 | Date29 Aug 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 1434-MDR-021/2025 Issued
Technical documentation EU MDR
- Notified body
- POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. 1434
- Issued
- 29 Aug 2025
- Expires
- 28 Aug 2030
Specification
- Device Name
- Dafodil™ Pericardial Bioprosthesis Valve
- Model / Reference
- DDL33M
- Primary DI / UDI-DI
- 18904224951188
- Basic UDI-DI
- 89042249PBE8
- Direct Marketing DI
- 18904224951188
- EMDN Code
- P070301010202 Stented mitral biological valves for surgical implant - non-valve tissue of animal origin
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- IN-MF-000008308
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Meril Life Sciences Pvt. Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED f7819103-cfd6-4e7e-8251-a30466447d11