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PRESTIGE 24i LQ UA
EUDAMEDClass IVD General (EU MDR)
Ref 4-208Model PRESTIGE 24i LQ UARef 4-408
Identity
- Trade Name
- PRESTIGE 24i LQ UA EUDAMED
- Device Name
- UA EUDAMED
- Model / Reference
- PRESTIGE 24i LQ UA EUDAMED4-208 EUDAMED4-408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907514642083 EUDAMED05907514644087 EUDAMED
- Basic UDI-DI
- B-05907514642083 EUDAMEDB-05907514644087 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland 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
Category: Uric acid IVD, reagent
PRESTIGE 24i LQ UA by PZ CORMAY Spółka Akcyjna — 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
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- 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-05907514642083 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- PZ CORMAY Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000023053
Sources (2)
- EUDAMED cee10a6b-31d5-4b7d-9fb1-41d195860d76 61 fields · synced Jul 11, 2026
- EUDAMED e099b939-d7a7-4f03-abba-dde8459f85c3 61 fields · synced May 17, 2026