Identity
- Trade Name
- RTM 78 HS EUDAMED
- Device Name
- X-ray tubes EUDAMED
- Model / Reference
- RTM 78 HS 0.6/1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059307491495 EUDAMED
- Basic UDI-DI
- 805930749385G4 EUDAMED
- Direct Marketing DI
- 08059307491495 EUDAMED
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Rtm 78 Hs by I.a.e. Industria Applicazioni Elettroniche S.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805930749385G4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- I.a.e. Industria Applicazioni Elettroniche S.p.a.
- EUDAMED SRN
- IT-MF-000021626
Sources (1)
- EUDAMED 6a0ea316-444d-42d0-9579-c6653c37082b 61 fields · synced Oct 6, 2026