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Uric acid - Liquizyme Uricase-PAP (Single Reagent)
EUDAMEDClass IVD General (EU MDR)
Ref 323 005Ref 323 001Ref 323 006Ref 323 003Ref 323 004
Identity
- Trade Name
- Uric acid - Liquizyme Uricase-PAP (Single Reagent) EUDAMED
- Device Name
- Uric acid - single reagent EUDAMEDUric acid - Liquizyme Uricase-PAP (Single Reagent) EUDAMED
- Model / Reference
- 323 005 EUDAMED323 001 EUDAMED323 006 EUDAMED323 003 EUDAMED323 004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041040394 EUDAMED62230041039954 EUDAMED62230041040462 EUDAMEDG4583230038H EUDAMEDG4583230068P EUDAMEDG4583230048K EUDAMED
- Basic UDI-DI
- B-62230041040394 EUDAMEDB-62230041039954 EUDAMEDB-62230041040462 EUDAMED++G458323MT EUDAMED
- EMDN Code
- W01010232 URIC ACID EUDAMEDW01010231 TRIGLYCERIDES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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 - Liquizyme Uricase-PAP (Single Reagent) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDR, IVDD — listed in…
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-62230041040394 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-62230041040394 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (6)
- EUDAMED 09fd2113-ebfe-4eed-af2f-e190ff1a37dc 61 fields · synced Jul 30, 2026
- EUDAMED 41af5bfa-81df-4fb1-bf69-7acdac809a24 61 fields · synced May 18, 2026
- EUDAMED 493c4fba-5dee-4a4f-a1ba-02feab6684ab 61 fields · synced May 19, 2026
- EUDAMED 1055c4d9-50f5-40de-bd56-562c8a7e3371 61 fields · synced Jul 9, 2026
- EUDAMED 02d8a10c-6b92-41fc-af43-7af4959c5a3e 61 fields · synced Jul 22, 2026
- EUDAMED 158ffa3d-35c8-4540-a05b-9eed15de6939 61 fields · synced Jul 30, 2026