Identity
- Trade Name
- Hydra EUDAMED
- Device Name
- Hydra aortic valve delivery catheter EUDAMED
- Model / Reference
- HYDRA18F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08858788502030 EUDAMED
- Basic UDI-DI
- B-08858788502030 EUDAMED
- EMDN Code
- P07038002 CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hydra 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-08858788502030 | 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 80e569bb-80df-429f-838f-49b4ad5c7515 61 fields · synced Oct 9, 2026