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Ventripoint Medical System Plus
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref K241222Model VMS+ 4.0510(k) K241222
Identity
- Trade Name
- Ventripoint Medical System Plus EUDAMED
- Device Name
- Ventripoint Medical System Plus EUDAMED
- Model / Reference
- VMS+ 4.0 EUDAMEDK241222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540263000032 EUDAMED
- Basic UDI-DI
- 7540263VMS+4YF EUDAMED
- EMDN Code
- Z11040192 ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Ventripoint Medical System Plus by Ventripoint Diagnostics Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K241222 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7540263VMS+4YF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ventripoint Diagnostics Ltd.
- EUDAMED SRN
- CA-MF-000030095
- FDA Applicant
- Ventripoint Diagnostics , Ltd.
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (2)
- EUDAMED 71a21dd3-e3fa-45e3-8281-57e25c291dd6 85 fields · synced Jun 18, 2026
- FDA 510(k) K241222 1 fields · synced May 18, 2026