Identity
- Trade Name
- CPE Shoe covers blue EUDAMED
- Device Name
- Shoe covers for single use EUDAMED
- Model / Reference
- Shoe covers EUDAMEDCHSC01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586006512713 EUDAMED
- Basic UDI-DI
- 858601504SHOECOVERS25H6 EUDAMED
- Direct Marketing DI
- 08586006512713 EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
CPE Shoe covers blue by CHIRANA T.Injecta, a.s. — 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 | 858601504SHOECOVERS25H6 | Class I | Active |
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Manufacturer
- Manufacturer
- CHIRANA T.Injecta, a.s.
- EUDAMED SRN
- SK-MF-000003702
Sources (1)
- EUDAMED 505aeb0b-1e27-4cff-93fe-9b5d974adb29 61 fields · synced Jul 14, 2026