Identity
- Trade Name
- Spare Endotracheal Neck Band EUDAMED
- Device Name
- Endotracheal Tube Holder EUDAMED
- Model / Reference
- CR4513 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060031483086 EUDAMED
- Basic UDI-DI
- 506003148EndoTubeHolCQ EUDAMED
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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
Spare Endotracheal Neck Band 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 | 506003148EndoTubeHolCQ | 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 0f357082-2c72-404e-8235-9f653aebbe45 61 fields · synced Jul 15, 2026