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Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition）
EUDAMEDClass IVD General (EU MDR)
Ref 3011681Model R1: 1x20mL, R2: 1x5mL, Calibration sample: 1x0.5mL, Control: 2x0.5mLRef 3011616Model R1：1x20mL, R2：1x5mL
Identity
- Trade Name
- Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition） EUDAMED
- Device Name
- Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition） EUDAMED
- Model / Reference
- R1: 1x20mL, R2: 1x5mL, Calibration sample: 1x0.5mL, Control: 2x0.5mL EUDAMED3011681 EUDAMEDR1：1x20mL, R2：1x5mL EUDAMED3011616 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202246500 EUDAMED06942202246494 EUDAMED
- Basic UDI-DI
- B-06942202246500 EUDAMEDB-06942202246494 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
Mitochondrial Aspartate Aminotransferase Reagent Kit（Immunoinhibition） 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-06942202246500 | 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 ff85be61-8d58-414c-9944-e872d71d395c 61 fields · synced Jul 14, 2026
- EUDAMED 3f031f26-eba5-4fc2-8970-18edad968e14 61 fields · synced May 19, 2026