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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

RTC 1000 HS — 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

RTC 1000 HS

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: 08059307491204
Reference / catalog number: RTC 1000 HS 0.6/1.2

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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: RTC 1000 HS
UDI-DI code: 08059307491204
Basic UDI-DI: 805930749385G4
Reference / catalog number: RTC 1000 HS 0.6/1.2
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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