Pathology Image Management System
Ref WinSlideLib
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697743004WinSlideLibPZ 06977430041016 | Date5 Feb 2026 | 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- Withdrawn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/IVDR Active
Specification
- Device Name
- Pathology Image Management System
- Model / Reference
- WinSlideLib
- Primary DI / UDI-DI
- 06977430041016
- Basic UDI-DI
- 697743004WinSlideLibPZ
- EMDN Code
- W0299 IVD instruments - other
- Device Class
- Class A
- Special Device Type
- Software
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000041945
- Authorised representative
- Sungo Cert GmbH DE-AR-000010869
Other devices from Winmedic Tech Co., Ltd.
Properties
Other properties (10)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No