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Uric Acid Mono Sl
EUDAMEDClass B (EU MDR)
Ref AUML-0427Model AUML-0250Ref AUML-M830Ref AUML-0420Ref AUML-5710Ref AUML-5505
Identity
- Trade Name
- URIC ACID MONO SL EUDAMEDURIC ACID EUDAMED
- Device Name
- URIC ACID MONO SL EUDAMEDURIC ACID EUDAMED
- Model / Reference
- AUML-0250 EUDAMEDAUML-0427 EUDAMEDAUML-M830 EUDAMEDAUML-0420 EUDAMEDAUML-5710 EUDAMEDAUML-5505 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700816607 EUDAMED03701700801603 EUDAMED03701700816508 EUDAMED03701700817017 EUDAMED03701700816713 EUDAMED
- Basic UDI-DI
- 37017008AUML00AF EUDAMED37017008AUML01AH EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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 Mono Sl by Vitalscientific — Class B — IVDR — 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
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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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008AUML00AF | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (5)
- EUDAMED c492ebec-890c-4221-8ec5-c2d58253a79c 61 fields · synced Aug 1, 2026
- EUDAMED ec430fa0-25b8-494b-86dd-6aa8e9d93a2e 61 fields · synced May 16, 2026
- EUDAMED f4919607-890d-47e6-adfb-372a5a14e060 61 fields · synced May 17, 2026
- EUDAMED 737519e7-192c-42de-bb79-56379b2e2ea5 61 fields · synced May 18, 2026
- EUDAMED ef2ef037-c6c0-475e-91b4-364aeb263611 61 fields · synced Jul 15, 2026