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Winston-Lutz Marker
EUDAMEDClass I (EU MDR)
Ref 50-335Model Winston-Lutz Marker
Identity
- Trade Name
- Winston-Lutz Marker EUDAMED
- Device Name
- Lutz Marker Position System EUDAMED
- Model / Reference
- Winston-Lutz Marker EUDAMED50-335 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365503350 EUDAMED
- Basic UDI-DI
- ++B365ELEKTAACCESZL EUDAMED
- Direct Marketing DI
- +B365503350 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
Winston-Lutz Marker 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 | ++B365ELEKTAACCESZL | 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 (1)
- EUDAMED 727f7ff1-a22a-4680-8095-daa6fc2cfb3b 61 fields · synced Oct 6, 2026