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Tracheostomy Tube Holder Paediatric
EUDAMEDClass I (EU MDR)
Ref CR4510Model 507906-000000
Identity
- Trade Name
- Tracheostomy Tube Holder Paediatric EUDAMED
- Device Name
- Tracheostomy Neck Band EUDAMED
- Model / Reference
- 507906-000000 EUDAMEDCR4510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031483161 EUDAMED
- Basic UDI-DI
- 506003148TracheoNeckS6 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
Tracheostomy Tube Holder Paediatric 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 | 506003148TracheoNeckS6 | 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 607429ab-915d-406d-92fc-3c65a29c8142 61 fields · synced Jul 12, 2026