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Pspix2
EUDAMEDClass I (EU MDR)
Ref S_702_0015Model S_702_0001Ref S_702_0006Ref 990215Ref 990266Ref 990252Ref 990264Ref 990237Ref 990239Ref S_702_0003Ref 990267Ref 990285Ref 990218Ref 990238Ref S_702_0010
by Sopro
Identity
- Trade Name
- PSPIX2 EUDAMEDPSPIX2 Intraoral Imaging Plate EUDAMED
- Device Name
- PSPIX2 EUDAMEDPSPIX2 Intraoral Imaging Plate EUDAMED
- Model / Reference
- S_702_0001 EUDAMEDS_702_0015 EUDAMEDS_702_0006 EUDAMED990215 EUDAMED990266 EUDAMED990252 EUDAMED990264 EUDAMED990237 EUDAMED990239 EUDAMEDS_702_0003 EUDAMED990267 EUDAMED990285 EUDAMED990218 EUDAMED990238 EUDAMEDS_702_0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278263688 EUDAMED03760278260908 EUDAMED03760278263237 EUDAMED03760278263282 EUDAMED03760278266252 EUDAMED03760278263268 EUDAMED03760278266122 EUDAMED03760278266146 EUDAMED03760278260892 EUDAMED03760278263299 EUDAMED03760278260878 EUDAMED03760278267679 EUDAMED03760278263244 EUDAMED03760278266139 EUDAMED03760278260922 EUDAMED
- Basic UDI-DI
- 801337602782D0001CP EUDAMED801337602782D0002CR EUDAMED
- Direct Marketing DI
- 03760278260434 EUDAMED03760278260892 EUDAMED
- EMDN Code
- Z110601 LASER IMAGING SCANNER EUDAMEDZ1103040101 EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass 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 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 (15)
- EUDAMED 215540c7-8cfa-4fd9-9748-a536098ba769 61 fields · synced Sep 18, 2026
- EUDAMED d0b97ded-55b0-4192-8010-e2a75dbf4918 61 fields · synced May 16, 2026
- EUDAMED c1c11cf1-257a-42c0-a920-b50813c8287e 61 fields · synced May 16, 2026
- EUDAMED 8457b83d-6514-40e4-865e-533875332d2f 61 fields · synced May 16, 2026
- EUDAMED 621ac9c4-b8fb-4994-a1d5-d8c969576c27 61 fields · synced May 17, 2026
- EUDAMED 758bd599-996d-4b9b-8d0d-561401cb550a 61 fields · synced May 17, 2026
- EUDAMED 2476febe-7d35-4c7f-88e3-4b719698575d 61 fields · synced May 17, 2026
- EUDAMED 96c8dfe8-a5ce-4d61-884f-41309f213c80 61 fields · synced May 17, 2026
- EUDAMED af149df7-f888-418d-bc6d-46549ee69f33 61 fields · synced May 18, 2026
- EUDAMED 8cfae9c6-87e9-4fbe-bcbc-b7c6b3933767 61 fields · synced May 18, 2026
- EUDAMED c1aade7b-17bd-4a89-aa15-b825b212bab0 61 fields · synced May 18, 2026
- EUDAMED 2ada2843-3343-4a6a-b4b0-a93f66ce60ee 61 fields · synced May 18, 2026
- EUDAMED f49f579e-3628-43e8-b4c7-4650060611a5 61 fields · synced May 18, 2026
- EUDAMED 9953e5bc-8640-460a-b6e1-106b8ebce1ac 61 fields · synced May 18, 2026
- EUDAMED 119200d4-6997-40d7-877e-16d3f9303aff 61 fields · synced Jun 18, 2026