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Glutathione Reductase Reagent Kit (Glutathione Substrate Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3021637Model R1: 2x60mL, R2: 2x15mL，Calibration sample: 1x1mL, Control: 1x1mLRef 3021530Model R1: 2x60mL, R2: 2x15mL
Identity
- Trade Name
- Glutathione Reductase Reagent Kit (Glutathione Substrate Assay) EUDAMED
- Device Name
- Glutathione Reductase Reagent Kit (Glutathione Substrate Assay) EUDAMED
- Model / Reference
- R1: 2x60mL, R2: 2x15mL，Calibration sample: 1x1mL, Control: 1x1mL EUDAMED3021637 EUDAMEDR1: 2x60mL, R2: 2x15mL EUDAMED3021530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794592491 EUDAMED06925794592507 EUDAMED
- Basic UDI-DI
- B-06925794592491 EUDAMEDB-06925794592507 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
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
Glutathione Reductase Reagent Kit (Glutathione 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-06925794592491 | 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 (2)
- EUDAMED 7fff8f24-7a22-45d7-83f7-301c5f8d0b42 61 fields · synced Aug 3, 2026
- EUDAMED 7f3ca641-e7a9-4b58-8d68-bc068cb34591 61 fields · synced May 16, 2026