Identity
- Device Name
- Shoe Cover EUDAMED
- Model / Reference
- FY1617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977206051461 EUDAMED
- Basic UDI-DI
- 697720605Cover01U9 EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Shoe Cover by Ningbo Foyomed Medical Instruments Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697720605Cover01U9 | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Foyomed Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000032266
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED c1daab24-81b3-4ee9-a39c-efbe607649d2 61 fields · synced Jul 8, 2026