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Blood Glucose and β-ketone Meter
EUDAMEDClass A (EU MDR)
Ref EN511Ref EN513Ref EN510
Identity
- Device Name
- Blood Glucose and β-ketone Meter EUDAMED
- Model / Reference
- EN511 EUDAMEDEN513 EUDAMEDEN510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975022535066 EUDAMED06975022535080 EUDAMED06975022535059 EUDAMED
- Basic UDI-DI
- 69750225319112CEMG 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
Blood Glucose and β-ketone 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 | 69750225319112CEMG | 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 (3)
- EUDAMED b52c838a-69ba-430e-9fa2-ac6ab9fe30ca 61 fields · synced Jul 30, 2026
- EUDAMED f6fc2951-9d54-42fd-a23b-4461b7f249fd 61 fields · synced May 18, 2026
- EUDAMED 34b7ed17-d6ee-411d-a39c-b1e01d4a2930 61 fields · synced May 18, 2026