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Shoe Cover - SBPP
EUDAMEDClass I (EU MDR)
Ref Shoe Cover - SBPPModel Shoe Cover - HDPE, Shoe Cover - LDPE, Shoe Cover - CPE, Shoe Cover - PVC, Shoe Cover - SBPP, Shoe Cover - SBPP Coated, Shoe Cover - SBPP coated with micro-porous film
Identity
- Trade Name
- Shoe Cover - SBPP EUDAMED
- Device Name
- Shoe Cover EUDAMED
- Model / Reference
- Shoe Cover - HDPE, Shoe Cover - LDPE, Shoe Cover - CPE, Shoe Cover - PVC, Shoe Cover - SBPP, Shoe Cover - SBPP Coated, Shoe Cover - SBPP coated with micro-porous film EUDAMEDShoe Cover - SBPP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00697549344223 EUDAMED
- Basic UDI-DI
- 697549344SHOECOVERS93 EUDAMED
- Direct Marketing DI
- 00697549344223 EUDAMED
- EMDN Code
- T0208 SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 - SBPP by Carestone Medical & Protective 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 | 697549344SHOECOVERS93 | Class I | Active |
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Manufacturer
- Manufacturer
- Carestone Medical & Protective Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000027756
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 5d5ff562-55e6-4af2-a0a8-f5457b9fefb9 61 fields · synced Jun 18, 2026