Cholesterol Reagent Kit(enzyme Method)
by Dirui Industrial Co., Ltd 8 variants
Ref 232012502008Model R1: 4x50mL, R2: 1x50mL,Calibration sample: 2mL
Cholesterol Reagent Kit(enzyme Method) (232012502008) is a device classified as IVD General made by Dirui Industrial Co., Ltd, registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI B-06942202239885), active as of 24 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06942202239885 06942202239885 | Date22 Jul 2026 | StatusActive |
Official records
- EUDAMED public site B-06942202239885
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- Withdrawn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/IVDD Active
Specification
- Model / reference
- R1: 4x50mL, R2: 1x50mL,Calibration sample: 2mL, 232012502008
- Primary DI / UDI-DI
- 06942202239885
- Basic UDI-DI
- B-06942202239885
- EMDN code
- W01010205 Cholesterol
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000001891
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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