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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

C40 — 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 10, 2023

C40

805930749384G2

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: 08059307491457
Reference / catalog number: C40

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View device family (Basic UDI)

Manufacturer information

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

Related devices

C100805930749384G2On the market C100 XS805930749384G2On the market C100 XT805930749384G2On the market C20805930749384G2On the market C30805930749384G2On the market

Certificates

Certificate health across this manufacturer's portfolio.

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

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
The equipment use must thus be strictly limited to qualified personnel under the guide of a radiologist, who can determine the correct exposure parameters and establish a risk to benefit ratio
CW258
Beware of any hot part and / or surface
CW011
All of the following operations must be performed with system electrically disconnected

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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: C40
UDI-DI code: 08059307491457
Basic UDI-DI: 805930749384G2
Reference / catalog number: C40
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 unit 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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