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Sofshield Laryngectomy Protector
EUDAMEDClass I (EU MDR)
Ref AS3765Model AS3669 - Large White
Identity
- Trade Name
- Sofshield Laryngectomy Protector EUDAMED
- Device Name
- Sofshield Laryngectomy Protector EUDAMED
- Model / Reference
- AS3669 - Large White EUDAMEDAS3765 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031471144 EUDAMED
- Basic UDI-DI
- 506003147Sofshield9K EUDAMED
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Sofshield Laryngectomy Protector by Brightwake Limited — 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 | 506003147Sofshield9K | Class I | Active |
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Manufacturer
- Manufacturer
- Brightwake Limited
- EUDAMED SRN
- GB-MF-000012039
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (1)
- EUDAMED 50f6d419-c228-4d91-8d75-fe5696dbaccb 61 fields · synced Jun 18, 2026