Identity
- Trade Name
- Myval™ OCTAPRO+ EUDAMED
- Device Name
- Myval™ OCTAPRO+ Transcatheter Heart Valve EUDAMED
- Model / Reference
- Model 5 EUDAMEDMOCTAPRP5320 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904224971025 EUDAMED
- Basic UDI-DI
- B-18904224971025 EUDAMED
- EMDN Code
- P070301030201 STENTED BIOLOGICAL AORTIC VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria 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
Myval OCTAPRO+ is a cutting-edge, implantable transcatheter heart valve designed for patients requiring durable and reliable replacement. This innovative device offers unparalleled performance, ensuring optimal heart function and improved quality of life.
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-18904224971025 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000008308
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 0f52e425-9621-41fa-b019-cfa17302759c 61 fields · synced Jul 25, 2026