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Oral-Pharyngeal Airway
EUDAMEDFDA UDIClass I (EU MDR)
Ref PA040109Model Guedel Airway
Identity
- Trade Name
- Oral-Pharyngeal Airway EUDAMEDGuedel Airway, Size 9.0 FDA UDI
- Generic Name
- Oropharyngeal airway, single-use FDA UDI
- Device Name
- Oral-Pharyngeal Airway EUDAMED
- Model / Reference
- Guedel Airway EUDAMEDPA040109 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- PA040109 FDA UDI
- Primary DI / UDI-DI
- 06923310902953 EUDAMEDFDA UDI
- Basic UDI-DI
- 69233109PA04018G 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Oral-Pharyngeal Airway by Hangzhou Formed Medical Devices 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 | 69233109PA04018G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 2da9ba1e-2688-4c38-a65b-974b87966d44 61 fields · synced Jul 22, 2026
- FDA UDI 6fb33b5e-a589-4f4f-87ec-7028a5074cd5 33 fields · synced May 30, 2026