Identity
- Trade Name
- DREAM Center EUDAMED
- Device Name
- Medical Image Management And Processing System EUDAMED
- Model / Reference
- Picasso EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975480280195 EUDAMED
- Basic UDI-DI
- 697548028PICV8 EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
DREAM Center by Intalight Group Co., Ltd. — Class I — 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 | 697548028PICV8 | Class I | Active |
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Manufacturer
- Manufacturer
- Intalight Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000025982
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 088b7519-5acf-4d05-ab4f-ada1afff4ffb 61 fields · synced Jun 18, 2026