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Shoe cover
EUDAMEDClass I (EU MDR)
Ref SC53102983Model 15*36cm,15*40cm, 17*40cm, 19*40cm, 19*42cm
Identity
- Trade Name
- Shoe cover EUDAMED
- Device Name
- Shoe cover EUDAMED
- Model / Reference
- 15*36cm,15*40cm, 17*40cm, 19*40cm, 19*42cm EUDAMEDSC53102983 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05319992314121 EUDAMED
- Basic UDI-DI
- 5319992314SCO019J EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 Astra M Medpro — 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 | 5319992314SCO019J | Class I | Active |
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Manufacturer
- Manufacturer
- Astra M Medpro
- EUDAMED SRN
- MK-MF-000047216
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 622a9e2d-009b-4de3-846f-a2930ccf1ac3 61 fields · synced Jun 17, 2026