Identity
- Trade Name
- NASOPHARYNGEAL AIRWAY EUDAMEDEMSRUN FDA UDI
- Generic Name
- Coronary artery infusion catheter FDA UDINasopharyngeal airway, single-use FDA UDI
- Device Name
- NASOPHARYNGREAL AIRWAY EUDAMED
- Model / Reference
- CR-B1 EUDAMEDFDA UDICR-B1-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567743417 EUDAMEDFDA UDI06974567743462 FDA UDI
- Basic UDI-DI
- 697456774CR-B1M6 EUDAMED
- FDA Product Code
- JCY FDA UDIBTQ FDA UDI
- EMDN Code
- R010101 NASOPHARYNGEAL TUBES EUDAMED
- GMDN Term
- Coronary artery infusion catheter FDA UDINasopharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4200 FDA UDI868.5100 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
Category: Nasopharyngeal airway, single-use
Nasopharyngeal Airway by Wuxi Emsrun Technology 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
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-B1M6 | 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 (3)
- EUDAMED 1e0a33cb-5e07-437f-9149-c96dc06b0dc3 61 fields · synced Jun 19, 2026
- FDA UDI 3db830b9-ac7a-428f-ad3d-1ee70b21fe73 32 fields · synced May 29, 2026
- FDA UDI 17d52ea7-96db-4d44-9ba2-a1d9007c7013 32 fields · synced May 30, 2026