Identity
- Trade Name
- Electrolyte solution EUDAMEDKCL Electrolyte Solution FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI
- Device Name
- KCL Electrolyte Solution H917 EUDAMEDTo provide constant electrical potential through the reference electrode. FDA UDI
- Model / Reference
- BM-820639D EUDAMEDFDA UDI
- Description
- To provide constant electrical potential through the reference electrode. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403012725 EUDAMEDFDA UDI
- Basic UDI-DI
- 081140301BM820639DFN EUDAMED
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMED
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte 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
Electrolyte 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 | 081140301BM820639DFN | 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 cd959ada-ff4e-42bd-adcb-9db8ddad361c 61 fields · synced Jun 19, 2026
- FDA UDI b8ae0cc2-2bd2-4b66-b662-5e97c0a2c65a 33 fields · synced May 30, 2026