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Uric Acid (UA)
EUDAMEDClass IVD General (EU MDR)
Ref ECH 0101054Ref ECH 0105054Ref ECH0104054
Identity
- Device Name
- Uric Acid (UA) EUDAMED
- Model / Reference
- ECH 0101054 EUDAMEDECH 0105054 EUDAMEDECH0104054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ECH01010544S EUDAMEDD-ECH01050545N EUDAMEDD-ECH01040545F EUDAMED
- Basic UDI-DI
- B-ECH01010544S EUDAMEDB-ECH01050545N EUDAMEDB-ECH01040545F 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 (UA) by Maccura Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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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-ECH01010544S | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED bb02446f-247f-4757-ae3b-3877ad8b714f 61 fields · synced Aug 3, 2026
- EUDAMED a949d3dc-0957-4744-8e95-eed7af342ddb 61 fields · synced May 18, 2026
- EUDAMED edc84e9c-d613-45d4-ac81-ca7ba04cfe9a 61 fields · synced May 18, 2026