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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

DRF_03_005 — Class IIb MDR by Digitec S.r.l.

MD Atlas
Digitec S.r.l.

EUDAMED last updated this device on Feb 20, 2026

DRF_03_005

805347039TIRESYAWB

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Digitec S.r.l.
UDI-DI code: 08053470390074
Reference / catalog number: DRF_03_005

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View device family (Basic UDI)

Manufacturer information

Organization name: Digitec S.r.l.
SRN: IT-MF-000007792
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.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Nov 19, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08053470390074
Basic UDI-DI: 805347039TIRESYAWB
Reference / catalog number: DRF_03_005
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z11031192SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - 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

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Related devices

3DCam C8053470393DCAMZ6On the market DRF_01_010805347039TIRESYAWBOn the market DRF_01_002805347039TIRESYAWBOn the market DRF_01_001805347039TIRESYAWBOn the market ARM_01_006805347039TIRESYAWBOn the market

Certificates

Certificate health across this manufacturer's portfolio.

ITH 1450755 1Supplemented
Quality management systemNotified body: 1936Expiry: Dec 28, 2027