Standard performance leikkaustakki
Ref 4F013A24560XLModel 4F013
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 | Number64180104F013A24JU 06418010344719 | Date21 Dec 2021 | 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- Withdrawn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
- Standard performance leikkaustakki
- Model / Reference
- 4F013, 4F013A24560XL
- Primary DI / UDI-DI
- 06418010344719
- Basic UDI-DI
- 64180104F013A24JU
- Direct Marketing DI
- 06418010344719
- EMDN Code
- T020402 Reinforced surgical gowns
- Device Class
- Class I
- EU market of registration
- Finland
Manufacturer details
- EUDAMED SRN
- FI-MF-000018231
Other devices from Image Wear Oy
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