Identity
- Trade Name
- Dafodil™ Neo EUDAMEDDafodil™ EUDAMED
- Device Name
- Dafodil™ Pericardial Bioprosthesis Valve EUDAMEDDafodil Neo™ Pericardial Bioprosthesis EUDAMED
- Model / Reference
- DDLN25A EUDAMEDDDLN27A EUDAMEDDDL33M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224930862 EUDAMED18904224930879 EUDAMED18904224951188 EUDAMED
- Basic UDI-DI
- 89042249PBE8 EUDAMEDB-18904224930862 EUDAMED
- Direct Marketing DI
- 18904224930862 EUDAMED18904224930879 EUDAMED18904224951188 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 EUDAMEDP070301010202 STENTED MITRAL BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-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 — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 89042249PBE8 | Class III | Active |
| EUDAMED | European Union | CE/MDD | 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 (4)
- EUDAMED aa29dc2f-65e8-4557-994a-4ad16007f7a9 61 fields · synced Aug 4, 2026
- EUDAMED 9f2a705c-097a-4b1c-8409-ce1dc787f1d3 61 fields · synced May 17, 2026
- EUDAMED f923267a-7fc7-4143-8a4b-85a2b7052af0 61 fields · synced May 17, 2026
- EUDAMED f7819103-cfd6-4e7e-8251-a30466447d11 61 fields · synced May 19, 2026