Primovert
by Carl Zeiss Suzhou Co., Ltd. 3 variants
Ref 415510-1100-000Model Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7
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 | Number6909262CNA002QB 06909262210049 | Date28 Jan 2023 | 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- Withdrawn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
- Inverted microscope
- Model / Reference
- Axiovert 5 / Primovert / Axio Vert.A1/Axiovert 7, 415510-1100-000
- Primary DI / UDI-DI
- 06909262210049
- Basic UDI-DI
- 6909262CNA002QB
- Direct Marketing DI
- 06909262210049
- EMDN Code
- W0202050303 Optical laboratory microscopes
- Device Class
- Class A
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000017606
- Authorised representative
- Carl Zeiss Microscopy GmbH DE-AR-000024425
Other devices from Carl Zeiss Suzhou 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