Identity
- Trade Name
- Ion Selective Analyzer EUDAMED
- Device Name
- CareLyte Plus Electrolyte Analyzer EUDAMED
- Model / Reference
- 0-DD-CARELYTEPLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00811403010011 EUDAMED
- Basic UDI-DI
- 0811403010DDCARELYTEPLKS EUDAMED
- EMDN Code
- W0201040201 ION SELECTIVE ELECTROLYTE ANALYSERS 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
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
Ion Selective Analyzer 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 | 0811403010DDCARELYTEPLKS | 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 (1)
- EUDAMED f62d471e-7314-4163-abe2-f17c6bfd76a6 61 fields · synced Jul 8, 2026