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Flomero™
EUDAMEDClass III (EU MDR)
Ref FLOM19ARef FLOM29ARef FLOM33MRef FLOM21ARef FLOM25ARef FLOM31MRef FLOM23A
Identity
- Trade Name
- Flomero™ EUDAMED
- Device Name
- Dafodil™ Pericardial Bioprosthesis Valve EUDAMED
- Model / Reference
- FLOM19A EUDAMEDFLOM29A EUDAMEDFLOM33M EUDAMEDFLOM21A EUDAMEDFLOM25A EUDAMEDFLOM31M EUDAMEDFLOM23A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224930732 EUDAMED18904224951232 EUDAMED18904224951249 EUDAMED18904224930749 EUDAMED18904224930763 EUDAMED18904224930824 EUDAMED18904224930756 EUDAMED
- Basic UDI-DI
- 89042249PBE8 EUDAMED
- Direct Marketing DI
- 18904224930732 EUDAMED18904224951232 EUDAMED18904224951249 EUDAMED18904224930749 EUDAMED18904224930763 EUDAMED18904224930824 EUDAMED18904224930756 EUDAMED
- EMDN Code
- P070301010201 STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-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
Flomero™ by Meril Life Sciences Pvt. Ltd. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (7)
- EUDAMED 13582c6f-00c9-46a9-b51d-6464e76fedfb 61 fields · synced Aug 1, 2026
- EUDAMED 071fdfab-3c19-41e3-9b1d-9af1179c4d51 61 fields · synced May 16, 2026
- EUDAMED 27c6d263-ecbc-45a2-9e1b-71847aabf9bf 61 fields · synced May 16, 2026
- EUDAMED 59484f1e-982e-4cbf-85aa-03d138076ec1 61 fields · synced May 17, 2026
- EUDAMED c25652c7-6b29-4363-bbec-8149742682f7 61 fields · synced May 17, 2026
- EUDAMED f972167d-2d80-402a-ae99-e894786f2c5b 61 fields · synced May 17, 2026
- EUDAMED 1f0bfe94-fb37-45e7-99ef-5bc5eee3c723 61 fields · synced May 17, 2026