Disposable Shoe Covers
by Jiangsu Medplus Non-woven Manufacturer Co., Ltd. EUDAMED
Active
Ref I
Overview
The Disposable Shoe Covers are a revolutionary medical device designed to provide an additional layer of protection and hygiene for healthcare professionals, making it easier to maintain sterile conditions in clinical settings. This disposable shoe cover is engineered with advanced non-woven materials that absorb moisture and prevent the spread of microorganisms, reducing the risk of infection.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697170524shoecovers85 | Date10 Nov 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- I
- Primary DI / UDI-DI
- 06932523051143
- Basic UDI-DI
- 697170524shoecovers85
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000022548
- Authorised representative
- MedPath GmbH DE-AR-000000087
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No