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Acido Urico
EUDAMEDClass IVD General (EU MDR)
Ref 4050/50Ref 4059Ref 4050Ref BT4050
Identity
- Trade Name
- Acido Urico EUDAMEDAcido Urico - Biotecnica Systems EUDAMED
- Device Name
- Acido Urico/Uric Acid EUDAMEDAcido Urico/Uric Acid - Biotecnica Systems EUDAMED
- Model / Reference
- 4050/50 EUDAMED4059 EUDAMED4050 EUDAMEDBT4050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053172970994 EUDAMED08053172971014 EUDAMED08053172971007 EUDAMED08053172972844 EUDAMED
- Basic UDI-DI
- B-08053172970994 EUDAMEDB-08053172971014 EUDAMEDB-08053172971007 EUDAMEDB-08053172972844 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Acido Urico by Giesse Diagnostics Srl — Class IVD General — 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-08053172970994 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Giesse Diagnostics Srl
- EUDAMED SRN
- IT-MF-000039031
Sources (4)
- EUDAMED b6da46a8-79b9-4eb4-bf4e-1ebd2f706186 61 fields · synced Sep 17, 2026
- EUDAMED 49ad8ea3-f828-42ab-a3ee-de576fdf39e3 61 fields · synced May 18, 2026
- EUDAMED 09b6a246-d630-4830-9301-1b3bfe71046e 61 fields · synced May 19, 2026
- EUDAMED f5362f11-5013-416b-b4f1-6e6e63ee1399 61 fields · synced May 19, 2026