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Shoe Cover
EUDAMEDClass I (EU MDR)
Ref MC117.3Model MC117.1 MC117.2 MC117.3 MC117.4 MC117.5 MC117.6 MC117.7 MC117.8 MC117.9 MC117.10 MC117.11 MC117.12 MC118.1 MC118.2 MC118.3 MC118.4 MC118.5 or Customized Size
Identity
- Device Name
- Shoe Cover EUDAMED
- Model / Reference
- MC117.1 MC117.2 MC117.3 MC117.4 MC117.5 MC117.6 MC117.7 MC117.8 MC117.9 MC117.10 MC117.11 MC117.12 MC118.1 MC118.2 MC118.3 MC118.4 MC118.5 or Customized Size EUDAMEDMC117.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975883470810 EUDAMED06975883474191 EUDAMED
- Basic UDI-DI
- 697588347ShoeCoverCR EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Hospital & Homecare Medical Device Co., Ltd. China — 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 | 697588347ShoeCoverCR | Class I | Active |
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Manufacturer
- Manufacturer
- Hospital & Homecare Medical Device Co., Ltd. China
- EUDAMED SRN
- CN-MF-000032014
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ae573ee7-3c8f-499f-a2d4-2f90318681bc 61 fields · synced Oct 6, 2026
- EUDAMED f8fd6161-f70d-4952-b276-bc4540e9718c 61 fields · synced Oct 6, 2026