Identity
- Trade Name
- HYDRA Aortic Valve EUDAMED
- Device Name
- Hydra aortic valve EUDAMED
- Model / Reference
- HYDRA30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08858788502023 EUDAMED
- Basic UDI-DI
- B-08858788502023 EUDAMED
- EMDN Code
- P070301030204 STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
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-08858788502023 | 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 (1)
- EUDAMED c43fa8d8-0db9-4509-be68-fe3c6ec375cb 61 fields · synced Oct 9, 2026