Identity
- Trade Name
- EasyLyte Neo Potassium Electrode EUDAMED
- Device Name
- EasyLyte Neo Analyzer EUDAMED
- Model / Reference
- 30101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00379497006407 EUDAMED
- Basic UDI-DI
- 0379497ELNAKClCaQL EUDAMED
- Direct Marketing DI
- 00379497006407 EUDAMED
- EMDN Code
- W0101070106 POTASSIUM - ELECTRODES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Greece 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
Yes
EUDAMED
EasyLyte Neo Potassium Electrode by Medica Corp. — Class B — 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 | 0379497ELNAKClCaQL | Class B | Active |
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Manufacturer
- Manufacturer
- Medica Corporation
- EUDAMED SRN
- US-MF-000037250
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED ce8e0406-2da6-4284-8aeb-bcfcad6ffca9 61 fields · synced Jun 19, 2026