Reagent Kit for Automatic Biochemistry Analyzer

Ref RM-R03-014-1.0Model 10T/BOX, 30T*3/BOX, 20T*10/BOX, 20T/BOX, 30T*4/BOX, 20T *2/BOX, 30T/BOX, 30T *2/BOX, 30T*5/BOX

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD

Ended

Withdrawn

Date not published (CE IVDD)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06979845480022 Basic UDI-DI	Date6 Jul 2026Registered	StatusWithdrawn No longer placed on the EU market

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

1 jurisdiction

European Union — CE/IVDD Withdrawn

EUDAMED

Device Name: Reagent Kit for Automatic Biochemistry Analyzer
Model / Reference: 10T/BOX, RM-R03-014-1.0, 30T*3/BOX, 20T*10/BOX, 20T/BOX, 30T*4/BOX, 20T *2/BOX, 30T/BOX, 30T *2/BOX, 30T*5/BOX

Primary DI / UDI-DI: 06979845480022, 06979845480077, 06979845480107, 06979845480039, 06979845480084, 06979845480053, 06979845480046, 06979845480060, 06979845480091
Basic UDI-DI: B-06979845480022, B-06979845480077, B-06979845480107, B-06979845480039, B-06979845480084, B-06979845480053, B-06979845480046, B-06979845480060, B-06979845480091
EMDN Code: W01010404 Multiple parameters (mix of all) - clin. chem lab r.