cTnI Control (CLIA)
Ref QC507
cTnI Control (CLIA) (QC507) is a device classified as IVD General made by Getein Biotech, Inc, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-06954414747904), active as of 7 Nov 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-06954414747904 | Date5 Nov 2026 | StatusActive |
Official records
- EUDAMED public site B-06954414747904
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- Withdrawn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
- QC507
- Primary DI / UDI-DI
- 06954414747904, 06954414753370, 06954414754414, 06954414755589
- Basic UDI-DI
- B-06954414747904, B-06954414753370, B-06954414754414, B-06954414755589
- EMDN code
- W0102152004 Cardiac marker controls
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000017986
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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