Identity
- Trade Name
- Thermoplastic Mask EUDAMED
- Device Name
- PosiLok Standard Mask Kit (single) EUDAMED
- Model / Reference
- Thermoplastic Mask EUDAMED40-723 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B365407231 EUDAMED
- Basic UDI-DI
- ++B365THERMMASKKD EUDAMED
- Direct Marketing DI
- +B365407231 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
Thermoplastic Mask 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 | ++B365THERMMASKKD | 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 0cdc8184-7001-42c3-ac2d-6f78e5d74790 61 fields · synced Jun 18, 2026