Fluorescence Microscopy Imaging System
by Shenzhen Tiantong Diagnostic Technology Co., Ltd. 2 variants
Ref 001Model HDS24-01,HDS24-02
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 | Number698030518HDS24CS 06980305180017 | Date13 Aug 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- Withdrawn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
- Model / Reference
- HDS24-01,HDS24-02, 001
- Primary DI / UDI-DI
- 06980305180017
- Basic UDI-DI
- 698030518HDS24CS
- EMDN Code
- W0202050301 Electron microscopes
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000057588
- Authorised representative
- GRZAN GmbH DE-AR-000038821
Other devices from Shenzhen Tiantong Diagnostic Technology 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
- Professional Testing: No
- Companion Diagnostics: No
- New Device: No