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UASure II
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref S5640955, S5640956
Identity
- Trade Name
- UASure II EUDAMED
- Device Name
- UASure II Blood uric acid test strips EUDAMED
- Model / Reference
- S5640955, S5640956 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487605AUT3F EUDAMED
- Basic UDI-DI
- B-47136487605AUT3F EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
UASure II by Apex Biotechnology Corp. — Class IVD devices for self-testing — 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-47136487605AUT3F | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Apex Biotechnology Corp.
- EUDAMED SRN
- TW-MF-000019773
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED bd4d917c-b459-4161-b284-0238dfec7cc6 61 fields · synced May 23, 2026