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Uric Acid Reagent Kit（uricase Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3016555Model R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mLRef 3021562Model R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mLRef 3000636Model R1: 4x80mL, R2: 4x20mL, Calibration sample: 2mLRef 3023194Ref 3016509Ref 3000638Model R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mLRef 3000640Model R1: 4x50mL, R2: 2x25mL, Calibration sample: 2mL
Identity
- Trade Name
- URIC ACID REAGENT KIT（URICASE METHOD） EUDAMED
- Device Name
- URIC ACID REAGENT KIT（URICASE METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mL EUDAMED3016555 EUDAMEDR1: 4x50mL, R2: 2x25mL，Calibration sample: 2mL EUDAMED3021562 EUDAMEDR1: 4x80mL, R2: 4x20mL, Calibration sample: 2mL EUDAMED3000636 EUDAMED3023194 EUDAMED3016509 EUDAMEDR1: 2x60mL, R2: 2x15mL, Calibration sample: 2mL EUDAMED3000638 EUDAMEDR1: 4x50mL, R2: 2x25mL, Calibration sample: 2mL EUDAMED3000640 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259647 EUDAMED06925794592972 EUDAMED06942202259616 EUDAMED06942202213359 EUDAMED06942202259630 EUDAMED06942202259609 EUDAMED06942202257414 EUDAMED
- Basic UDI-DI
- B-06942202259647 EUDAMEDB-06925794592972 EUDAMEDB-06942202259616 EUDAMEDB-06942202213359 EUDAMEDB-06942202259630 EUDAMEDB-06942202259609 EUDAMEDB-06942202257414 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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（uricase Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Uric acid IVD, reagent.
- 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
- ACE — Alfa Wassermann, Inc. · Class I
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-06942202259647 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (7)
- EUDAMED d958861f-253e-48a6-9138-ca80b80e38c4 61 fields · synced Jul 30, 2026
- EUDAMED adf56e04-f2df-4d12-a6b2-90034a468b54 61 fields · synced May 18, 2026
- EUDAMED e8fa3e40-4cde-4440-b5ff-cfe4a96df7d3 61 fields · synced May 18, 2026
- EUDAMED 7e21fc1d-ad94-4a82-920c-43b3c2984bed 61 fields · synced May 18, 2026
- EUDAMED 4b3b99f0-81ec-4693-b17d-8a8c4f7ebc45 61 fields · synced May 18, 2026
- EUDAMED 8c5e7592-efc8-47d3-ad4b-4c82a8a326cc 61 fields · synced May 18, 2026
- EUDAMED 2af0b193-2122-4043-b3de-7484a7cf5c82 61 fields · synced May 19, 2026