Identity
- Trade Name
- CPR mask EUDAMEDEMSRUN FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- CPR mask EUDAMED
- Model / Reference
- CR-PP01、CR-PP02 EUDAMEDCR-CPR03 EUDAMEDPZMZ0021 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567742755 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-PP01W5 EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES EUDAMED
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5580 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
CPR mask 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-PP01W5 | 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 e37189a2-4254-4cfc-905a-e620f84348b2 61 fields · synced Jun 17, 2026
- FDA UDI 2a019a08-4c7c-4bf1-a730-7539b5528ff6 32 fields · synced May 30, 2026