Disposable Laboratory Shoe Covers
by Prosenso ApS EUDAMED
Active
Ref EWSHOE35M-UN
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number57450012040001GT | Date28 Nov 2024 | 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- Withdrawn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
- Device Name
- Disposable Laboratory Shoe Cover UN
- Model / Reference
- EWSHOE35M-UN
- Primary DI / UDI-DI
- 05745001204006
- Basic UDI-DI
- 57450012040001GT
- Direct Marketing DI
- 05745001204006
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- DK-MF-000043015
Other devices from Prosenso ApS
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