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Reference solution
EUDAMEDFDA UDIClass A (EU MDR)
Ref AV-BP0095DRef OY-AUH1017D
Identity
- Trade Name
- Reference solution EUDAMEDInternal Reference Solution FDA UDI
- Generic Name
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
- Device Name
- Reference Solution AW EUDAMEDISE Internal Reference Solution, AU EUDAMED
- Model / Reference
- AV-BP0095D EUDAMEDOY-AUH1017D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403010035 EUDAMED00811403017010 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301AVBP0095D47 EUDAMED081140301OYAUH1017D7H EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Ion selective electrode (ISE) reference solution IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Reference solution by DIAMOND DIAGNOSTICS Inc — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081140301AVBP0095D47 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 00c3ba88-41c7-4c8b-8787-64b5973c379a 61 fields · synced Jul 15, 2026
- EUDAMED 9a631f8e-a9e8-40a2-b719-a95a5f4c6da9 61 fields · synced May 18, 2026
- FDA UDI e7539f61-0ae9-429a-a3b5-136a077e4e38 32 fields · synced May 29, 2026