Ochraniacze na buty, foliowe, niebieskie
by Saltec Tomasz Kirsz 2 variants
Ref OBPEN100B, OBPEN100, OBPEN100H
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5906124322ochraniacze49 | Date23 Nov 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Ochraniacze na buty
- Model / Reference
- OBPEN100B, OBPEN100, OBPEN100H
- Primary DI / UDI-DI
- 05906124322163, 05906124322125, 05906124322149
- Basic UDI-DI
- 5906124322ochraniacze49
- EMDN Code
- T0208 Shoe covers (excluding personal protective equipment - PPE)
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000038779
Other devices from Saltec Tomasz Kirsz
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