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HYDRA Aortic Valve
EUDAMEDClass III (EU MDR)
Ref HYDRA26Ref HYDRA18VLSRef HYDRA22
Identity
- Trade Name
- HYDRA Aortic Valve EUDAMEDHydra EUDAMED
- Device Name
- Hydra aortic valve EUDAMEDaortic valve loading system EUDAMED
- Model / Reference
- HYDRA26 EUDAMEDHYDRA18VLS EUDAMEDHYDRA22 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08858788502016 EUDAMED08858788502047 EUDAMED08858788502009 EUDAMED
- Basic UDI-DI
- B-08858788502016 EUDAMEDB-08858788502047 EUDAMEDB-08858788502009 EUDAMED
- EMDN Code
- P070301030204 STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN EUDAMEDP07038002 CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMEDPoland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMEDEUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HYDRA Aortic Valve by Vascular Innovations Co. Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08858788502016 | Class III | Active |
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Manufacturer
- Manufacturer
- Vascular Innovations Co. Ltd.
- EUDAMED SRN
- TH-MF-000028144
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 4c2acd02-44db-445a-8d3a-1f3dbd609454 61 fields · synced Oct 7, 2026
- EUDAMED da9751b0-71d3-4019-8086-b90bc7203785 61 fields · synced May 17, 2026
- EUDAMED bb6d2460-fb7f-425f-8f87-422fb5f08131 61 fields · synced May 18, 2026