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PSPIX2 Intraoral Imaging plate
EUDAMEDClass IIa (EU MDR)
Ref 990216Model 990215
by Sopro
Identity
- Trade Name
- PSPIX2 Intraoral Imaging plate EUDAMED
- Device Name
- PSPIX2 Intraoral Imaging Plate EUDAMED
- Model / Reference
- 990215 EUDAMED990216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278263213 EUDAMED
- Basic UDI-DI
- 801337602782D0002CR EUDAMED
- EMDN Code
- Z1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa 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 Intraoral Imaging plate by Sopro — 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 | 801337602782D0002CR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (1)
- EUDAMED 6afeca92-0d9e-4f4a-983a-ffa4323a55dc 61 fields · synced Jun 18, 2026