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Oropharyngeal Airway
EUDAMEDClass I (EU MDR)
Ref GA80SModel Oropharyngeal Airway (Guedel Type)
Identity
- Device Name
- Oropharyngeal Airway EUDAMED
- Model / Reference
- Oropharyngeal Airway (Guedel Type) EUDAMEDGA80S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240893608 EUDAMED
- Basic UDI-DI
- 697024089OASQP EUDAMED
- Direct Marketing DI
- 06970240893608 EUDAMED
- EMDN Code
- R010199 NASO-OROPHARYNGEAL TUBES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Oropharyngeal Airway by Ningbo Luke Medical Devices Co., LTD — 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 | 697024089OASQP | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Luke Medical Devices Co., LTD
- EUDAMED SRN
- CN-MF-000011732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8b871211-fdc4-4218-ad81-056894a62e77 61 fields · synced Jun 11, 2026