Digital Pathology Slide Scanner
by Winmedic Tech Co., Ltd. 8 variants
Ref Win180, Win-300-Pro-S, Win-RD-Pro, Win-CD-Pro, Win20, Win-40-Pro, Win-ED-Pro-S, HS480, Win-ED-Pro, Win-120-Pro-S, Win-300-ProModel Science/Win20/Win60/Win180/HS480/SMART/Win-RD-Pro/Win-RD-Pro-S/Win-40-Pro/Win-40-Pro-S/Win-ED-Pro/Win-ED-Pro-S/Win-120-Pro/Win-120-Pro-S/Win-CD-Pro/Win-CD-Pro-S/Win-300-Pro/Win-300-Pro-S
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 | Number697743004WMDPSSVW | Date15 May 2024 | 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- Withdrawn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
- Digital Pathology Slide Scanner
- Model / Reference
- Science/Win20/Win60/Win180/HS480/SMART/Win-RD-Pro/Win-RD-Pro-S/Win-40-Pro/Win-40-Pro-S/Win-ED-Pro/Win-ED-Pro-S/Win-120-Pro/Win-120-Pro-S/Win-CD-Pro/Win-CD-Pro-S/Win-300-Pro/Win-300-Pro-S, Win180, Win-300-Pro-S, Win-RD-Pro, Win-CD-Pro, Win20, Win-40-Pro, Win-ED-Pro-S, HS480, Win-ED-Pro, Win-120-Pro-S, Win-300-Pro
- Primary DI / UDI-DI
- 06977430040033, 06977430040170, 06977430040064, 06977430040149, 06977430040019, 06977430040088, 06977430040118, 06977430040040, 06977430040101, 06977430040132, 06977430040163
- Basic UDI-DI
- 697743004WMDPSSVW
- Direct Marketing DI
- 0697743004003306977430040170069774300400640697743004014906977430040019069774300400880697743004011806977430040040069774300401010697743004013206977430040163
- EMDN Code
- W0299 IVD instruments - other
- Device Class
- Class A
- EU market of registration
- Italy
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 (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No