Identity
- Device Name
- shoe/boot cover EUDAMED
- Model / Reference
- 40002 EUDAMED40003B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16973219624033 EUDAMED06973219624005 EUDAMED
- Basic UDI-DI
- 697321962104JS EUDAMED
- Unit of Use DI
- 06973219624036 EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDAustria 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/boot cover by Ammex-Weida (Hubei) Health and Safety Products 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 | 697321962104JS | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011701
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED a871423d-d93e-4bae-868b-2accc74b876b 61 fields · synced Oct 7, 2026
- EUDAMED de8c2189-d8de-4a43-ae3a-eebcc3dd1bf4 61 fields · synced May 18, 2026