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Organization name
UDI-DI code
Reference / catalog number

PSPIX2 Intraoral Imaging plate — Class IIa MDR by SOPRO

MD Atlas
SOPRO

EUDAMED last updated this device on Jan 27, 2026

PSPIX2 Intraoral Imaging plate

801337602782D0002CR

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SOPRO
UDI-DI code: 03760278263268
Reference / catalog number: 990264

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Manufacturer information

Organization name: SOPRO
SRN: FR-MF-000000833
Manufacturer status: Active

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54.0950.00 - C20 CAMERA HANDPIECE801337602782D0004CVOn the market S_C20_0004801337602782D0004CVOn the market C20 - INTRAORAL CAMERA801337602782D0004CVOn the market C20 INTRAORAL CAMERA + AIS801337602782D0004CVOn the market S_C50_0002801337602782D0006CZOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Voir IFU réf 011812

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Nov 21, 2014	Still on market

Device identification

Trade name: PSPIX2 Intraoral Imaging plate
UDI-DI code: 03760278263268
Basic UDI-DI: 801337602782D0002CR
Reference / catalog number: 990264
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Imaging plate size 0 for Ukraine and Russia
Additional information URL: https://www.acteongroup.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z1103040101EQUIPMENT FOR CONVENTIONAL ENDORAL RADIOLOGY

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
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