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UASure II
EUDAMEDFDA 510(k)Class IVD devices for self-testing (EU MDR)
Ref S5800386510(k) K242209Ref S5640752
Identity
- Trade Name
- UASure II EUDAMEDUASure EUDAMED
- Device Name
- UASure II uric acid control solution EUDAMEDUASure Uric Acid Test Strips EUDAMED
- Model / Reference
- S5800386 EUDAMEDS5640752 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-47136487605AUS3D EUDAMEDD-47136487604A05Y EUDAMED
- Basic UDI-DI
- B-47136487605AUS3D EUDAMEDB-47136487604A05Y EUDAMED
- 510(k) Number
- K242209 FDA 510(k)
- FDA Product Code
- PTC FDA 510(k)
- EMDN Code
- W010106010801 BLOOD TEST STRIPS CONTROLS EUDAMEDW01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1775 FDA 510(k)
- Regulation Number
- 862.1775 FDA 510(k)
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
UASure II by Apex Biotechnology Corp. — Class IVD devices for self-testing — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242209 | Class IVD devices for self-testing | Active |
| EUDAMED | European Union | CE/IVDD | B-47136487605AUS3D | 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 (3)
- EUDAMED 2e3e0882-e337-4aec-beaf-64e3fd4ce0bc 61 fields · synced Jul 30, 2026
- FDA 510(k) K242209 24 fields · synced May 18, 2026
- EUDAMED 78a4d112-5f12-4f0a-bbbb-ffc651dca0bc 61 fields · synced Jul 9, 2026