Identity
- Trade Name
- EasyLyte Neo 1200ml Solution Pack EUDAMED
- Device Name
- EasyLyte Neo Analyzer EUDAMED
- Model / Reference
- 30202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00379497006339 EUDAMED
- Basic UDI-DI
- 0379497ELNAKClCaQL EUDAMED
- Direct Marketing DI
- 00379497006339 EUDAMED
- EMDN Code
- W01010403 MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R. 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 1200ml Solution Pack 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 0f39c684-574b-408f-b9b4-d2213d5fbcd3 61 fields · synced Jul 11, 2026