← Back to catalogue
Uric Acid Kit (Uricase-Peroxidase Method)
EUDAMEDClass B (EU MDR)
Ref 105-001623-00Model 105-000848-00、105-000887-00、105-001623-00Ref 105-000848-00
Identity
- Trade Name
- Uric Acid Kit (Uricase-Peroxidase Method) EUDAMED
- Device Name
- Uric Acid Kit (Uricase-Peroxidase Method) EUDAMED
- Model / Reference
- 105-000848-00、105-000887-00、105-001623-00 EUDAMED105-001623-00 EUDAMED105-000848-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904026435 EUDAMED06944904025049 EUDAMED
- Basic UDI-DI
- 694490400041UA*********VB EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
Category: Uric acid IVD, reagent
Uric Acid Kit (Uricase-Peroxidase Method) by Shenzhen Mindray Bio-Medical Electronics Co., LTD — Class B — IVDR — listed in EUDAMED
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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 694490400041UA*********VB | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED f07e41d1-7963-46a2-9e41-9a1b78cf5b52 61 fields · synced Sep 18, 2026
- EUDAMED d5a0f5f2-f945-4a04-8be8-6df559d6d19f 61 fields · synced May 17, 2026