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Isocitrate Dehydrogenase Reagent Kit（the Substrate Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3021612Model R1: 4x50mL, R2: 2x25mLRef 3005689
Identity
- Trade Name
- ISOCITRATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD） EUDAMED
- Device Name
- ISOCITRATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD） EUDAMED
- Model / Reference
- R1: 4x50mL, R2: 2x25mL EUDAMED3021612 EUDAMED3005689 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794593597 EUDAMED06942202259043 EUDAMED
- Basic UDI-DI
- B-06925794593597 EUDAMEDB-06942202259043 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
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
Isocitrate Dehydrogenase Reagent Kit（the Substrate Method） 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-06925794593597 | 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 6c188c03-86c9-4aae-90ae-9a192148846b 61 fields · synced Jul 30, 2026
- EUDAMED 005fdd01-a1b6-420f-addd-b1d57a285473 61 fields · synced May 19, 2026