Naso-Pharyngeal Airway
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Naso-Pharyngeal Airway EUDAMEDNaso-Pharyngeal Airway, Size 9.0 FDA UDI
- Generic Name
- Nasopharyngeal airway, single-use FDA UDI
- Device Name
- Naso-Pharyngeal Airway EUDAMED
- Model / Reference
- Flange Type EUDAMEDPA190290 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- PA190290 FDA UDI
- Primary DI / UDI-DI
- 06923310901413 EUDAMEDFDA UDI
- Basic UDI-DI
- 69233109PA19029J EUDAMED
- FDA Product Code
- BTQ FDA UDI
- EMDN Code
- R010101 NASOPHARYNGEAL TUBES EUDAMED
- GMDN Term
- Nasopharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5100 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Nasopharyngeal airway, single-use
Naso-Pharyngeal Airway by Hangzhou Formed Medical Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69233109PA19029J | 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 49b2371d-d60e-43b4-9f87-391f478d97ac 61 fields · synced Jul 12, 2026
- FDA UDI 98a3bc55-c449-4afb-97f3-35a34c0bf127 33 fields · synced May 30, 2026