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Calibration solution
EUDAMEDClass A (EU MDR)
Ref CD-104227ADRef DD-61012Ref RD-943770D
Identity
- Trade Name
- Calibration solution EUDAMED
- Device Name
- 348 Cal-Pack EUDAMEDFluid Pack Unity EUDAMEDTHB Calibration Solution EUDAMED
- Model / Reference
- CD-104227AD EUDAMEDDD-61012 EUDAMEDRD-943770D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811403010318 EUDAMED00811403014576 EUDAMED00811403017331 EUDAMED
- Basic UDI-DI
- 081140301CD104227ADC6 EUDAMED081140301DD610127Z EUDAMED081140301RD943770DQ7 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
Calibration 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 | 081140301CD104227ADC6 | 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 (3)
- EUDAMED 243be23e-e769-4ab3-b7a4-f04af152af70 61 fields · synced Sep 18, 2026
- EUDAMED 9cf7d4cf-6223-4c15-801e-f19521f61566 61 fields · synced May 18, 2026
- EUDAMED bcf1f0ce-44a0-4b1c-8303-dd3a09d3be0e 61 fields · synced May 18, 2026