Identity
- Trade Name
- RTM 80 H EUDAMED
- Device Name
- X-ray tubes EUDAMED
- Model / Reference
- RTM 80 H 0.3/0.8 EUDAMEDRTM 80 H 0.3/0.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059307491525 EUDAMED08059307491549 EUDAMED
- Basic UDI-DI
- 805930749385G4 EUDAMED
- Direct Marketing DI
- 08059307491525 EUDAMED08059307491549 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
Category: Electromagnetic surgical navigation device tracking system
Rtm 80 H by I.a.e. Industria Applicazioni Elettroniche S.p.a. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electromagnetic surgical navigation device tracking system.
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- IA091S — ALFAMED SRL · Class IIa
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- Needle Holder — Shandong Chengwu Medical Products Factory · Class I
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- Nadeln / Needles — REDA Instrumente GmbH · Class I
- SCS MedSeries® H50 — Planmed Oy · Class IIb
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- I.a.e. Industria Applicazioni Elettroniche S.p.a.
- EUDAMED SRN
- IT-MF-000021626
Sources (2)
- EUDAMED 1511d870-1cae-4b27-b175-ddd8046c7883 61 fields · synced Jul 9, 2026
- EUDAMED cfa4f276-7110-42fe-9acb-3d63be3d8fe9 61 fields · synced May 18, 2026