Identity
- Trade Name
- PSPIX2 EUDAMED
- Device Name
- PSPIX2 EUDAMED
- Model / Reference
- S_702_0001 EUDAMEDS_702_0013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278262421 EUDAMED
- Basic UDI-DI
- 801337602782D0001CP EUDAMED
- Direct Marketing DI
- 03760278260434 EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Pspix2 by Sopro — 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 | 801337602782D0001CP | Class I | Active |
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Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (1)
- EUDAMED a042a5f2-e1c2-4926-939a-6e75145d9cf3 61 fields · synced May 23, 2026