Identity
- Trade Name
- Electrolyte analyzer EUDAMEDSmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ FDA UDI
- Generic Name
- Ion-selective analyser IVD FDA UDI
- Device Name
- SmartLyte Plus Electrolyte Analyzer EUDAMEDThe SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer is a microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack every 4 hours throughout the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. FDA UDI
- Model / Reference
- 0-DD-SMARTLYTEPLUS EUDAMEDFDA UDI
- Description
- The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer is a microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack every 4 hours throughout the day or on request. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811403010028 EUDAMEDFDA UDI
- Basic UDI-DI
- 0811403010DDSMARTLYTEPLGT EUDAMED
- FDA Product Code
- JJE FDA UDICEM FDA UDIJGS FDA UDICGZ FDA UDIJFP FDA UDIJIH FDA UDI
- EMDN Code
- W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS EUDAMED
- GMDN Term
- Ion-selective analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 FDA UDI862.1600 FDA UDI862.1665 FDA UDI862.1170 FDA UDI862.1145 FDA UDI862.3560 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Electrolyte analyzer 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 | 0811403010DDSMARTLYTEPLGT | 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 1f1c3cf1-cb65-44de-9a07-f0c6e0bc285b 61 fields · synced Jul 19, 2026
- FDA UDI 59e64393-97ea-4ed0-b9ac-deb21aeec548 33 fields · synced May 30, 2026