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Uric Acid (UA) Kit (Uricase Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.01.07.EC.01
by Zybio Inc.
Identity
- Device Name
- Uric Acid (UA) Kit (Uricase Method) EUDAMED
- Model / Reference
- 01.09.01.07.EC.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967202783 EUDAMED
- Basic UDI-DI
- B-06941967202783 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 (UA) Kit (Uricase Method) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, reagent.
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- 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-06941967202783 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED fc7e72df-31e9-488e-92a2-c673ad191d33 61 fields · synced Aug 2, 2026