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Guedel Airway 50mm, Blue
EUDAMEDClass I (EU MDR)
Ref AW0046Model (B) Oropharyngeal airway
Identity
- Trade Name
- Guedel Airway 50mm, Blue EUDAMED
- Device Name
- Oropharyngeal airway EUDAMED
- Model / Reference
- (B) Oropharyngeal airway EUDAMEDAW0046 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 44710810084704 EUDAMED
- Basic UDI-DI
- 471081008NNBW98 EUDAMED
- EMDN Code
- R028099 RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Guedel Airway 50mm, Blue by GaleMed Corporation — 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 | 471081008NNBW98 | Class I | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 8594d550-808f-4946-a30b-d7011a7efd76 61 fields · synced Jun 20, 2026