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Cholinesterase
EUDAMEDClass IVD General (EU MDR)
Ref 1415-0260Ref 1419-0260Ref 1418-0267
Identity
- Trade Name
- CHOLINESTERASE EUDAMED
- Device Name
- CHOLINESTERASE EUDAMED
- Model / Reference
- 1415-0260 EUDAMED1419-0260 EUDAMED1418-0267 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309167425 EUDAMED05204309123018 EUDAMED05204309039876 EUDAMED
- Basic UDI-DI
- B-05204309167425 EUDAMEDB-05204309123018 EUDAMEDB-05204309039876 EUDAMED
- EMDN Code
- W01010111 CHOLINESTERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Cholinesterase by Medicon Hellas SA — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05204309167425 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (3)
- EUDAMED 2c2dd2a6-41d0-479d-b6fd-192d1ea22a37 61 fields · synced Jul 31, 2026
- EUDAMED ae793bad-da54-455b-bc11-8708991befc3 61 fields · synced May 17, 2026
- EUDAMED 966838a2-9afe-4c2c-a003-2853758c9fc0 61 fields · synced May 19, 2026