Identity
- Trade Name
- Vitrea EUDAMED
- Device Name
- Vitrea Advanced Visualization EUDAMED
- Model / Reference
- 7.16.3.SU02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850025268387 EUDAMED
- Basic UDI-DI
- 0850025268VitreaAVES EUDAMED
- Direct Marketing DI
- 00850025268387 EUDAMED
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Vitrea by Canon Medical Informatics, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850025268VitreaAVES | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Canon Medical Informatics, Inc.
- EUDAMED SRN
- US-MF-000020013
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4d8c4e19-220f-4f41-9420-ce4b4456492e 61 fields · synced Jun 9, 2026