Identity
- Trade Name
- CPR Face Shield EUDAMED
- Device Name
- CPR Face Shield EUDAMED
- Model / Reference
- 110109 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942272611093 EUDAMED
- Basic UDI-DI
- 69422726J1.02.25SV EUDAMED
- EMDN Code
- M9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- CPR Face Shield； Cleansing Wipes； Medical Gloves EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
CPR Face Shield by Firstar Healthcare Company Limited (guangzhou) — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192285 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69422726J1.02.25SV | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Firstar Healthcare Company Limited (guangzhou)
- EUDAMED SRN
- CN-PR-000037943
Sources (2)
- EUDAMED add0d5a8-eb5e-48ae-9680-71217746267d 61 fields · synced Oct 5, 2026
- FDA 510(k) K192285 1 fields · synced May 18, 2026