Identity
- Trade Name
- VIVO System EUDAMED
- Device Name
- VIVO System EUDAMED
- Model / Reference
- 9002-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851424007089 EUDAMED
- Basic UDI-DI
- 08514240079002-001VR EUDAMED
- Direct Marketing DI
- 00851424007089 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VIVO System by Catheter Precision, Inc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200313 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K183195 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08514240079002-001VR | Class I | Active |
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Manufacturer
- Manufacturer
- Catheter Precision, Inc
- EUDAMED SRN
- US-MF-000018898
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED c655ab4e-4d91-4ca6-b762-99e26b41eaf7 61 fields · synced Aug 1, 2026
- FDA 510(k) K200313 1 fields · synced May 18, 2026