Eluent C
by Shenzhen Lifotronic Technology Co., Ltd. 6 variants
Ref 0320200505Model 400 mL, 800 mL
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 | Number69703416803202040HJ 06975984060439 | Date24 Oct 2025 | 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- Withdrawn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
- 400 mL, 800 mL, 0320200505
- Primary DI / UDI-DI
- 06975984060439
- Basic UDI-DI
- 69703416803202040HJ
- EMDN Code
- W0103010299 Other haemoglobin (types) testing - other
- Device Class
- Class A
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000005654
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Other devices from Shenzhen Lifotronic Technology Co., Ltd.
See all devices from Shenzhen Lifotronic Technology Co., Ltd. →
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No