Identity
- Trade Name
- VivoCardio EUDAMEDVivoCardio® Cardiovascular Pressure Measurement (CPM) System EUDAMED
- Device Name
- VivoCardio® Cardiovascular Pressure Measurement (CPM) System EUDAMED
- Model / Reference
- U152301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971318440113 EUDAMED
- Basic UDI-DI
- 697131844001E88 EUDAMEDB-06971318440113 EUDAMED
- EMDN Code
- C019004 CARDIOVASCULAR MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMEDPoland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VivoCardio by Insight Lifetech Co., Ltd. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697131844001E88 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697131844001E88 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Insight Lifetech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011205
- Authorised Representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Sources (2)
- EUDAMED 8e1fbfcb-0ec3-455f-b693-95530960dbca 61 fields · synced Jul 8, 2026
- EUDAMED 690dd9b2-73d8-413a-ae04-d17f002549fa 61 fields · synced May 19, 2026