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Super Oxide Dismutase Reagent Kit (Pyrogallol Substrate Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3021610Model R1: 1x30mL, R2: 1x10mL, Calibration sample: 1x0.5mL, Control: 1x0.5mLRef 3021658Model R1: 1x30mL, R2: 1x10mLRef 3011922
Identity
- Trade Name
- Super Oxide Dismutase Reagent Kit (Pyrogallol Substrate Assay) EUDAMED
- Device Name
- Super Oxide Dismutase Reagent Kit (Pyrogallol Substrate Assay) EUDAMED
- Model / Reference
- R1: 1x30mL, R2: 1x10mL, Calibration sample: 1x0.5mL, Control: 1x0.5mL EUDAMED3021610 EUDAMEDR1: 1x30mL, R2: 1x10mL EUDAMED3021658 EUDAMED3011922 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794592309 EUDAMED06925794592316 EUDAMED06942202246609 EUDAMED
- Basic UDI-DI
- B-06925794592309 EUDAMEDB-06925794592316 EUDAMEDB-06942202246609 EUDAMED
- EMDN Code
- W01010199 ENZYMES - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Super Oxide Dismutase Reagent Kit (Pyrogallol Substrate Assay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED
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-06925794592309 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED dece3501-bb9b-4063-b3d3-8bd437458f0c 61 fields · synced Jul 19, 2026
- EUDAMED 2b377d7a-b58d-458e-83cd-cd7ac9bd4326 61 fields · synced May 19, 2026
- EUDAMED 02578e8f-5b91-448a-8733-094b48ac1c14 61 fields · synced May 19, 2026