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Freesia™
EUDAMEDClass III (EU MDR)
Ref FRS23MRef FRS29ARef FRS19ARef FRS23ARef FRS21ARef FRS25ARef FRS31M
Identity
- Trade Name
- Freesia™ EUDAMED
- Device Name
- Dafodil™ Pericardial Bioprosthesis Valve EUDAMED
- Model / Reference
- FRS23M EUDAMEDFRS29A EUDAMEDFRS19A EUDAMEDFRS23A EUDAMEDFRS21A EUDAMEDFRS25A EUDAMEDFRS31M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224930985 EUDAMED18904224951263 EUDAMED18904224930930 EUDAMED18904224930954 EUDAMED18904224930947 EUDAMED18904224930961 EUDAMED18904224931029 EUDAMED
- Basic UDI-DI
- 89042249PBE8 EUDAMED
- Direct Marketing DI
- 18904224930985 EUDAMED18904224951263 EUDAMED18904224930930 EUDAMED18904224930954 EUDAMED18904224930947 EUDAMED18904224930961 EUDAMED18904224931029 EUDAMED
- EMDN Code
- P070301010202 STENTED MITRAL BIOLOGICAL VALVES FOR SURGICAL IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN EUDAMEDP070301010201 STENTED AORTIC 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
Freesia™ 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 85ff4e15-2521-4587-9155-45f6c7e15585 61 fields · synced Aug 2, 2026
- EUDAMED eebb7d51-32fd-4ea9-a5e5-30a889a66172 61 fields · synced May 16, 2026
- EUDAMED c2d0490c-6e97-42be-b09b-11fbe55e902b 61 fields · synced May 17, 2026
- EUDAMED d50e7310-1e6b-4288-bdd9-1d5d6e5cf4fb 61 fields · synced May 17, 2026
- EUDAMED 9d77a8aa-b3d5-4d18-a954-b0a1fd396c99 61 fields · synced May 18, 2026
- EUDAMED 289f71d7-ddea-4d3a-93a9-ffe0a990ef22 61 fields · synced May 19, 2026
- EUDAMED 980113c5-6a0d-4229-a513-94d66a3cff38 61 fields · synced May 19, 2026