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Blood Glucose and Uric Acid Meter
EUDAMEDClass A (EU MDR)
Ref EN412Ref EN410Ref EN411Ref EN413
Identity
- Device Name
- Blood Glucose and Uric Acid Meter EUDAMED
- Model / Reference
- EN412 EUDAMEDEN410 EUDAMEDEN411 EUDAMEDEN413 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975022535110 EUDAMED06975022535097 EUDAMED06975022535103 EUDAMED06975022535127 EUDAMED
- Basic UDI-DI
- 69750225319113CEMM 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 Uric Acid 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 | 69750225319113CEMM | 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 (4)
- EUDAMED cd6b9832-8850-44a5-99e2-2e7b6f3ee83c 61 fields · synced Jul 25, 2026
- EUDAMED a18ef940-5646-4ee4-9d5f-ca02c20b4f40 61 fields · synced May 16, 2026
- EUDAMED fb9cc5dc-7fca-45d4-a822-c7371e1d41b5 61 fields · synced May 17, 2026
- EUDAMED ff713387-25d6-4e02-ad06-1849aaf1f897 61 fields · synced May 18, 2026