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Uric Acid Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref UA6011Y, UA6012Y, UA6013Y, UA6014Y, UA6015Y, UA6011N, UA6012N, UA6013N, UA6014N, UA6015N
Identity
- Trade Name
- Uric Acid Reagent Kit EUDAMED
- Device Name
- Uric Acid Reagent Kit EUDAMED
- Model / Reference
- UA6011Y, UA6012Y, UA6013Y, UA6014Y, UA6015Y, UA6011N, UA6012N, UA6013N, UA6014N, UA6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-UA601WA EUDAMED
- Basic UDI-DI
- B-UA601WA EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Uric acid IVD, reagent
Uric Acid Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, reagent.
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- URIC ACID Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Uric acid — Kalians Corporation · IVD General
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-UA601WA | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 0bf96ebf-eabc-4e9a-9461-4ec369cd7069 61 fields · synced Jun 20, 2026
- EUDAMED 0bf96ebf-eabc-4e9a-9461-4ec369cd7069-1 61 fields · synced Jun 9, 2026