← Back to catalogue
Sopix2
EUDAMEDClass IIa (EU MDR)
Ref S_802_0017Model S_802_0001.Ref S_802_0015Ref S_802_0003Ref S_802_0004Ref S_802_0013Ref S_802_0014
by Sopro
Identity
- Trade Name
- SOPIX2 EUDAMED
- Device Name
- SOPIX2 EUDAMED
- Model / Reference
- S_802_0001. EUDAMEDS_802_0017 EUDAMEDS_802_0015 EUDAMEDS_802_0003 EUDAMEDS_802_0004 EUDAMEDS_802_0013 EUDAMEDS_802_0014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760278263466 EUDAMED03760278266092 EUDAMED03760278264050 EUDAMED03760278264067 EUDAMED03760278263381 EUDAMED03760278263794 EUDAMED
- Basic UDI-DI
- 801337602782D0009D7 EUDAMED
- Direct Marketing DI
- 03760278260410 EUDAMED03760278267099 EUDAMED03760278267105 EUDAMED03760278260328 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
Similar devices
Also classified as Dental digital imaging sensor, intraoral.
- DC-Air™ Intraoral Sensor — Athlos Oy · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Schick — Dentsply International · Class II
- XIOS XG SELECT — SIRONA DENTAL, INC. · Class II
- CDR — SIRONA DENTAL, INC. · Class II
- XIOS XG SUPREME — SIRONA DENTAL, INC. · Class II
- SCHICK33 — SIRONA DENTAL, INC. · Class II
- XIOS XG WIFI — SIRONA DENTAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sopro
- EUDAMED SRN
- FR-MF-000000833
Sources (6)
- EUDAMED 49f6b4b8-03b0-42a1-847c-67ec269b92a8 61 fields · synced Jul 18, 2026
- EUDAMED 115af15e-af25-47ed-9b45-c81dc18a2993 61 fields · synced May 17, 2026
- EUDAMED f0127e01-8b8f-41a2-afc0-8dbec04d78df 61 fields · synced May 17, 2026
- EUDAMED 9764f02d-d337-49ca-9eab-2c5dd4e3eb82 61 fields · synced May 18, 2026
- EUDAMED 1364c963-57e9-4f57-b549-3e584cbe9dd8 61 fields · synced May 18, 2026
- EUDAMED 9e9f12ca-7a11-46fc-9df2-449d2eedecce 61 fields · synced May 18, 2026