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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

WeDiagnostiX — Class IIa MDR by WeDiagnostix

MD Atlas
WeDiagnostix

EUDAMED last updated this device on Jun 28, 2025

WeDiagnostiX

3770026948WDXAPIFZ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: WeDiagnostix
UDI-DI code: 03770026948002
Reference / catalog number: WeDiagnostiX

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Manufacturer information

Organization name: WeDiagnostix
SRN: FR-MF-000023186
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03770026948002
Basic UDI-DI: 3770026948WDXAPIFZ
Reference / catalog number: WeDiagnostiX
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: WeDiagnostiX provides dental health professionals with assistance in writing radiology reports. WeDiagnostiX is a computer-aided detection software device that analyses patients’ panoramic dental X-ray images in order to detect and number their teeth, to analyse the preexisting treatments, and to identify the pathologies at the dental and extra-dental level.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12119092VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

This device is not currently linked to any other device.

Certificates

Certificate health across this manufacturer's portfolio.

22M00016CRT01Issued
Quality management systemNotified body: 1912Expiry: Jan 13, 2030