Identity
- Trade Name
- Dafodil™ Neo EUDAMEDDafodil Neo™ EUDAMED
- Device Name
- Dafodil™ Pericardial Bioprosthesis Valve EUDAMEDDafodil™ Neo Pericardial Bioprosthesis EUDAMED
- Model / Reference
- DDLN19A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224930831 EUDAMED
- Basic UDI-DI
- 89042249PBE8 EUDAMEDB-18904224930831 EUDAMED
- Direct Marketing DI
- 18904224930831 EUDAMED
- EMDN Code
- P070301010201 STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN EUDAMEDP070301010101 STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dafodil™ Neo by Meril Life Sciences Pvt. Ltd. — Class III — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 89042249PBE8 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 89042249PBE8 | Class III | Active |
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Manufacturer
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000008308
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 27417675-be8f-423a-a916-32b61cee64f3 61 fields · synced Jul 31, 2026
- EUDAMED dbdc9114-c4e4-4fc4-9d10-d1519bcf0fbb 61 fields · synced May 19, 2026