Identity
- Trade Name
- Revivent TC EUDAMED
- Device Name
- Introducer Kit BVX-150RTC EUDAMED
- Model / Reference
- BVX-150RTC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860014024832 EUDAMED
- Basic UDI-DI
- B-00860014024832 EUDAMED
- EMDN Code
- J010399 IMPLANTABLE VENTRICULAR ASSISTANCE SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Revivent TC by BioVentrix Inc. — 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-00860014024832 | Class III | Active |
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Manufacturer
- Manufacturer
- BioVentrix Inc.
- EUDAMED SRN
- US-MF-000044097
- Authorised Representative
- Meditrial Srl IT-AR-000007805
Sources (1)
- EUDAMED 97333db3-5aba-470a-b12c-1ab298468637 61 fields · synced Jun 17, 2026