Identity
- Trade Name
- K1046942 EUDAMED
- Device Name
- Fixed equipment for radioscopy and radiography EUDAMED
- Model / Reference
- NAUTILUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053307590189 EUDAMED
- Basic UDI-DI
- 805330759ARCHIACFJ EUDAMED
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
K1046942 by Technix S.p.A. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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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 | 805330759ARCHIACFJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Technix S.p.A.
- EUDAMED SRN
- IT-MF-000007797
Sources (1)
- EUDAMED e885b8d8-4147-47b1-b6b4-c0b96fbb3819 61 fields · synced Jul 15, 2026