Slide Printer
by Shanghai THAN Medical Technology Co., Ltd 12 variants
Ref SP 830Model SP 6XX (00, 06, 10, 16, 20, 26, 30, 36, 40, 46), SP 8XX (00, 10, 20, 30)
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 | Number697762446THANSPZ6 06977624460135 | Date9 Jul 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- Withdrawn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
- Slide Printer
- Model / Reference
- SP 6XX (00, 06, 10, 16, 20, 26, 30, 36, 40, 46), SP 8XX (00, 30), SP 830
- Primary DI / UDI-DI
- 06977624460135
- Basic UDI-DI
- 697762446THANSPZ6
- EMDN Code
- W0202059017 Cassette / slide printers
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000042882
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Shanghai THAN Medical Technology Co., Ltd
See all devices from Shanghai THAN Medical Technology 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