Identity
- Trade Name
- Eye Shield EUDAMEDEMSRUN FDA UDI
- Generic Name
- Eye splash shield, single-use FDA UDI
- Device Name
- Eye Shield EUDAMED
- Model / Reference
- CR-EP01-1 EUDAMEDCR-EP01-2 EUDAMEDPZYZ0001-1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974567743486 EUDAMEDFDA UDI
- Basic UDI-DI
- 697456774CR-EP01TQ EUDAMED
- FDA Product Code
- HOY FDA UDI
- EMDN Code
- Q029001 RIGID MONOCULAR MASKS EUDAMED
- GMDN Term
- Eye splash shield, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4750 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
Eye Shield 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-EP01TQ | 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 c660bcb4-da09-4929-bf91-533b9fb14943 61 fields · synced Jul 10, 2026
- FDA UDI 44a88629-5a5b-49ec-b605-9561ef5e6dd8 32 fields · synced May 30, 2026