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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

XM12 — Class IIb MDR by I.A.E. INDUSTRIA…

MD Atlas
I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A.

EUDAMED last updated this device on May 15, 2023

XM12

805930749385G4

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A.
UDI-DI code: 08059307491242
Reference / catalog number: XM12 0.1/0.3

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Manufacturer information

Organization name: I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE S.P.A.
SRN: IT-MF-000021626
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

029/MDRAmended
Quality management systemNotified body: 0051Expiry: Apr 27, 2027

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement		Still on market

Device identification

Trade name: XM12
UDI-DI code: 08059307491242
Basic UDI-DI: 805930749385G4
Reference / catalog number: XM12 0.1/0.3
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: Rotating anode X-ray tube for radiography systems
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.

Z11039099VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER

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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