Identity
- Trade Name
- SOPIX2 EUDAMED
- Device Name
- SOPIX2 EUDAMED
- Model / Reference
- S_802_0001. EUDAMEDS_802_0007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278264098 EUDAMED
- Basic UDI-DI
- 801337602782D0009D7 EUDAMED
- Direct Marketing DI
- 03760278267105 EUDAMED
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL 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
Category: Dental digital imaging sensor, intraoral
Sopix2 by Sopro — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 801337602782D0009D7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (1)
- EUDAMED e3e5c628-7613-44df-98b4-04d04bddd1f7 61 fields · synced May 23, 2026