Identity
- Trade Name
- Dale 260 Airway Holder EUDAMED
- Device Name
- Airway Holder Short-Term Securement EUDAMED
- Model / Reference
- 260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00817612021121 EUDAMED
- Basic UDI-DI
- 08176120226069 EUDAMED
- EMDN Code
- R01038099 ENDOTRACHEAL TUBES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Dale 260 Airway Holder by Dale Medical Products, Inc. — 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 | 08176120226069 | Class I | Active |
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Manufacturer
- Manufacturer
- Dale Medical Products, Inc.
- EUDAMED SRN
- US-MF-000019061
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 5b8ccbfe-44e8-4298-88e4-c2c5ea65b7ed 61 fields · synced Oct 6, 2026