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Sopix2 Plug-In

EUDAMED

Class IIa (EU MDR)

Ref S_802_7003Model SOPIX SERIES

by Sopro

Identity

Trade Name
SOPIX2 PLUG-IN EUDAMED
Device Name
SOPIX2 PLUG-IN EUDAMED
Model / Reference
SOPIX SERIES EUDAMED
S_802_7003 EUDAMED

Identifiers

Primary DI / UDI-DI
03760278267167 EUDAMED
Basic UDI-DI
801337602782D0012CU EUDAMED
Direct Marketing DI
03760278266689 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 Plug-In by Sopro — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental digital imaging sensor, intraoral.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Sopro
EUDAMED SRN
FR-MF-000000833

Sources (1)

  • EUDAMED 10ed9ebb-c8f2-4689-846f-13c84af5fb5a 61 fields · synced Jun 17, 2026