Identity
- Trade Name
- OROPHARYNGEAL AIRWAY EUDAMEDEMSRUN FDA UDI
- Generic Name
- Oropharyngeal airway, single-use FDA UDI
- Device Name
- OROPHARYNGEAL AIRWAY EUDAMED
- Model / Reference
- CR-OA01 EUDAMEDCR-OA06 EUDAMEDPZTQ0017 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567742861 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-OA01TK EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R010199 NASO-OROPHARYNGEAL TUBES - OTHER 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
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
Yes
FDA UDI
Oropharyngeal Airway by Wuxi Emsrun Technology 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 | 697456774CR-OA01TK | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Emsrun Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000008968
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED f9767018-67d0-4943-9107-028621bc2a54 61 fields · synced Jun 18, 2026
- FDA UDI fe5d86e3-b39f-4eb5-8272-2c18728dbf42 32 fields · synced May 30, 2026