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Uric acid
EUDAMEDClass IVD General (EU MDR)
Ref D-643 005Ref D-643 004Ref D-643 003Ref D-643 007
Identity
- Trade Name
- Uric acid EUDAMED
- Device Name
- Uric acid EUDAMED
- Model / Reference
- D-643 005 EUDAMEDD-643 004 EUDAMEDD-643 003 EUDAMEDD-643 007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182706388 EUDAMED62230182706210 EUDAMED62230182706142 EUDAMED62230182706524 EUDAMED
- Basic UDI-DI
- B-62230182706388 EUDAMEDB-62230182706210 EUDAMEDB-62230182706142 EUDAMEDB-62230182706524 EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMED
Classification
- Device Class
- Class IVD General 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
Category: Uric acid IVD, reagent
Uric acid by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Uric acid IVD, reagent.
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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
- 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-62230182706388 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (4)
- EUDAMED 50238a93-c85f-4fc5-906d-e33ba2e23f5d 61 fields · synced Jul 18, 2026
- EUDAMED 8db1bce9-dda7-481f-a16e-5d5a84c6cb53 61 fields · synced May 18, 2026
- EUDAMED 9ab65154-5e5b-41ef-9061-c59b3c12c2ae 61 fields · synced May 18, 2026
- EUDAMED eaf4c582-a8a7-4f21-9ffc-7728ccfff434 61 fields · synced May 18, 2026