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Blood Uric Acid Test Strips
EUDAMEDClass IVD General (EU MDR)
Ref EN400R1、EN400R2、 EN400R3、EN400R4、
Identity
- Device Name
- Blood Uric Acid Test Strips EUDAMED
- Model / Reference
- EN400R1、EN400R2、 EN400R3、EN400R4、 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69750225320174CEKYTW EUDAMED
- Basic UDI-DI
- B-69750225320174CEKYTW EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER 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
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Blood Uric Acid 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-69750225320174CEKYTW | 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 8525a627-f777-44b9-a05d-acc7228eb070 61 fields · synced Jun 19, 2026