Identity
- Trade Name
- Guedel Airway 80mm, Green EUDAMEDN/A FDA UDI
- Generic Name
- Oropharyngeal airway, single-use FDA UDI
- Device Name
- Oropharyngeal airway EUDAMEDGuedel Airway 8cm, Green FDA UDI
- Model / Reference
- AW0005 EUDAMEDFDA UDI
- Description
- Guedel Airway 8cm, Green FDA UDI
Identifiers
- Catalog Number
- AW0005 FDA UDI
- Primary DI / UDI-DI
- 06923980101922 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801ND1CANF EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
- GMDN Term
- Oropharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Guedel Airway 80mm, Green by GaleMed (Xiamen) Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69239801ND1CANF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1c10bc04-c269-46cc-a8bd-72b0563e1004 61 fields · synced Jun 18, 2026
- FDA UDI 10c6893d-a7b0-4eda-a01d-876b72490f39 34 fields · synced May 30, 2026