Identity
- Trade Name
- Standard solution EUDAMEDStandard B Solution FDA UDI
- Generic Name
- Multiple electrolyte IVD, calibrator FDA UDI
- Device Name
- Standard B ISE Module EUDAMEDTo provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer. FDA UDI
- Model / Reference
- ME-5410D EUDAMEDFDA UDI
- Description
- To provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403015887 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301ME5410DEM EUDAMED
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Multiple electrolyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Standard 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 | 081140301ME5410DEM | 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 (2)
- EUDAMED fbbfb750-d8b2-42b8-9e81-6607f3c225d2 61 fields · synced Jul 9, 2026
- FDA UDI 42a9de30-ff36-4857-8088-570166aa1ef9 33 fields · synced May 30, 2026