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Blood Glucose and Lactate Meter
EUDAMEDClass A (EU MDR)
Ref EN312Ref EN313Ref EN311
Identity
- Device Name
- Blood Glucose and Lactate Meter EUDAMED
- Model / Reference
- EN312 EUDAMEDEN313 EUDAMEDEN311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975022535035 EUDAMED06975022535042 EUDAMED06975022535028 EUDAMED
- Basic UDI-DI
- 69750225319111CEMB 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 Lactate 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 | 69750225319111CEMB | 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 f2bf9df1-ffad-463e-934c-25b936986868 61 fields · synced Sep 17, 2026
- EUDAMED 99cc5b89-4fe7-400e-836c-b9a6bf562478 61 fields · synced May 18, 2026
- EUDAMED 21acc69e-7b14-438f-a655-0a81ea606cd2 61 fields · synced May 18, 2026