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Rtc 1000 Hs

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref RTC 1000 HS 0.4/1.2

by I.a.e. Industria Applicazioni Elettroniche S.p.a.

Identity

Trade Name
RTC 1000 HS EUDAMEDFDA UDI
Generic Name
X-ray system tube rotating anode assembly FDA UDI
Device Name
X-ray tubes EUDAMED
Rotating anode X-ray tube for radiography systems FDA UDI
Model / Reference
RTC 1000 HS 0.4/1.2 EUDAMED
0.4/1.2 FDA UDI
Description
Rotating anode X-ray tube for radiography systems FDA UDI

Identifiers

Primary DI / UDI-DI
08059307491587 EUDAMEDFDA UDI
Basic UDI-DI
805930749385G4 EUDAMED
Direct Marketing DI
08059307491587 EUDAMED
FDA Product Code
ITY FDA UDI
EMDN Code
Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
GMDN Term
X-ray system tube rotating anode assembly FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class I FDA UDI
Regulation Number
892.1760 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Rtc 1000 Hs by I.a.e. Industria Applicazioni Elettroniche S.p.a. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
I.a.e. Industria Applicazioni Elettroniche S.p.a.
EUDAMED SRN
IT-MF-000021626

Sources (2)

  • EUDAMED c550bd0e-ff58-4673-82d5-2bbe56c3858d 61 fields · synced Jun 9, 2026
  • FDA UDI e0c9a870-5ed6-42cb-a8fd-57cfdaa12e19 33 fields · synced May 30, 2026