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Uric Acid Test Strip
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref GL0425Model UAS1100 GL0425
Identity
- Trade Name
- Uric Acid Test Strip EUDAMED
- Device Name
- Uric Acid Test Strips EUDAMED
- Model / Reference
- UAS1100 GL0425 EUDAMEDGL0425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921807610282 EUDAMED
- Basic UDI-DI
- B-06921807610282 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Uric acid IVD, reagent
Uric Acid Test Strip by Beijing Lepu Medical Technology Co., Ltd. — Class IVD devices for self-testing — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, reagent.
- URIC ACID REAGENT KIT（URICASE METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Uric Acid (UA) — Maccura Biotechnology Co., Ltd. · IVD General
- Liquick Cor-UA 120 — PZ CORMAY Spółka Akcyjna · IVD General
- 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-06921807610282 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- Beijing Lepu Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000033011
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 65abed50-5000-4d67-ad09-6a1bd5c8ae78 61 fields · synced Jul 17, 2026