Identity
- Device Name
- Handheld electrochemical meter EUDAMED
- Model / Reference
- M421 EUDAMEDM422 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975022536513 EUDAMED
- Basic UDI-DI
- 69750225323111CEKE EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Handheld electrochemical meter by Eaglenos Sciences, 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 | 69750225323111CEKE | Class A | Active |
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Manufacturer
- Manufacturer
- Eaglenos Sciences, Inc.
- EUDAMED SRN
- CN-MF-000036801
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b743f923-8f94-4346-84ec-341771d8268e 61 fields · synced Jun 17, 2026