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Standard solution
EUDAMEDClass A (EU MDR)
Ref DA-S620DRef HM-Y052HRef OY-AUH1016ADRef SM-B03417501ADRef OY-AUH1016BDRef DA-S625D
Identity
- Trade Name
- Standard solution EUDAMED
- Device Name
- Quicklyte Standard A RXL EUDAMEDStd. B, Horiba EUDAMEDStandard Low Urine EUDAMEDISE Serum Standard LOW EUDAMEDStandard High Urine EUDAMEDStandard B IMT EUDAMED
- Model / Reference
- DA-S620D EUDAMEDHM-Y052H EUDAMEDOY-AUH1016AD EUDAMEDSM-B03417501AD EUDAMEDOY-AUH1016BD EUDAMEDDA-S625D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811403014187 EUDAMED00811403015528 EUDAMED00811403016556 EUDAMED00811403010509 EUDAMED00811403016563 EUDAMED00811403014194 EUDAMED
- Basic UDI-DI
- 081140301DAS620DJS EUDAMED081140301HMY052HTF EUDAMED081140301OYAUH1016ADRQ EUDAMED081140301SMB03417501ADJ3 EUDAMED081140301OYAUH1016BDRT EUDAMED081140301DAS625DK9 EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Standard solution by DIAMOND DIAGNOSTICS Inc — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081140301DAS620DJS | Class A | Active |
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Manufacturer
- Manufacturer
- Diamond Diagnostics Inc
- EUDAMED SRN
- US-MF-000035435
- Authorised Representative
- Diamond Diagnostics Inc. Magyarországi Fióktelepe HU-AR-000034351
Sources (6)
- EUDAMED 35b1a4de-3663-40ca-b299-e1e3859bde50 61 fields · synced Jul 23, 2026
- EUDAMED 8e0d9524-bc3d-416b-b420-d948e4c524fa 61 fields · synced May 16, 2026
- EUDAMED 1d80372c-596c-4582-9557-6a341ae3b90d 61 fields · synced May 17, 2026
- EUDAMED 8bfff2ad-0867-4e23-bc55-78ef4e1555a9 61 fields · synced May 17, 2026
- EUDAMED de6f2667-9352-4515-9c98-0ebc5b37e543 61 fields · synced May 18, 2026
- EUDAMED 71a2d429-78b3-4b02-9bfb-c688eadabf2f 61 fields · synced May 18, 2026