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Blood Lactate Test Strips
EUDAMEDClass IVD General (EU MDR)
Ref EN300R1、EN300R2、EN300R3、EN300R4
Identity
- Device Name
- Blood Lactate Test Strips EUDAMED
- Model / Reference
- EN300R1、EN300R2、EN300R3、EN300R4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69750225320171CEKHRT EUDAMED
- Basic UDI-DI
- B-69750225320171CEKHRT EUDAMED
- EMDN Code
- W0101060104 LACTATE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Lactate Test Strips by Eaglenos Sciences, Inc. — 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-69750225320171CEKHRT | Class IVD General | 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 e47ca65d-23bb-4f0e-af59-59a86e723fbd 61 fields · synced Jun 18, 2026