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CT Overlay
EUDAMEDClass I (EU MDR)
Ref 11-463Model CT OverlayRef 11-471Ref 11-465Ref 11-466Ref 11-462
Identity
- Trade Name
- CT Overlay EUDAMED
- Device Name
- CT Overlay. Siemens Emotion. EUDAMED
- Model / Reference
- CT Overlay EUDAMED11-463 EUDAMED11-471 EUDAMED11-465 EUDAMED11-466 EUDAMED11-462 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365114630 EUDAMED+B365114710 EUDAMED+B365114650 EUDAMED+B365114660 EUDAMED+B365114620 EUDAMED
- Basic UDI-DI
- ++B36511462EX EUDAMED
- Direct Marketing DI
- +B365114630 EUDAMED+B365114710 EUDAMED+B365114650 EUDAMED+B365114660 EUDAMED+B365114620 EUDAMED
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
CT Overlay by Aktina Medical Corp — Class I — 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 | ++B36511462EX | Class I | Active |
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Manufacturer
- Manufacturer
- Aktina Medical Corp
- EUDAMED SRN
- US-MF-000005935
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (5)
- EUDAMED 03b9c7f8-558a-407c-9a1c-9a0fefd90d9f 61 fields · synced Oct 6, 2026
- EUDAMED 3ffba759-fb76-418a-aeb5-aa527ada8bf6 61 fields · synced May 16, 2026
- EUDAMED 82f1260a-0079-463b-804b-ed65ee8e484b 61 fields · synced May 17, 2026
- EUDAMED e55bcfdf-394d-4fcd-beab-bd18af064028 61 fields · synced May 17, 2026
- EUDAMED 06d999b0-efaa-4a8f-8cae-3eece26ce161 61 fields · synced May 17, 2026