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Sofshield Laryngectomy Protector
EUDAMEDClass I (EU MDR)
Ref AS3764Model AS3669 - Large WhiteRef AS4051Ref AS4063Ref AS3778Ref AS3698
Identity
- Trade Name
- Sofshield Laryngectomy Protector EUDAMED
- Device Name
- Sofshield Laryngectomy Protector EUDAMED
- Model / Reference
- AS3669 - Large White EUDAMEDAS3764 EUDAMEDAS4051 EUDAMEDAS4063 EUDAMEDAS3778 EUDAMEDAS3698 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031471069 EUDAMED05060031478662 EUDAMED05060031482881 EUDAMED05060031471106 EUDAMED05060031470482 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 (5)
- EUDAMED d90f0cd7-91df-449b-bdea-dee9e4eb16e0 61 fields · synced Jul 30, 2026
- EUDAMED 4018543b-9064-4425-800e-6ae7be2b27fd 61 fields · synced May 17, 2026
- EUDAMED 8ee8807f-0d7c-4bdd-a51e-1f18cc65e014 61 fields · synced May 17, 2026
- EUDAMED 0ecc6080-6619-4a55-8985-39c69cd334b1 61 fields · synced May 18, 2026
- EUDAMED 4a720773-bda4-4e15-83b3-ec7c3779a0b1 61 fields · synced May 18, 2026