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Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3011484Model R1: 1x20mL, R2: 1x10mLRef 3011816Model R1: 1x20mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mLRef 3012875Model R1: 1x20mL, R2: 1x10mL， Calibration sample: 1x1mL, Control: 2x1mL
Identity
- Trade Name
- Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay) EUDAMED
- Device Name
- Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition Assay) EUDAMED
- Model / Reference
- R1: 1x20mL, R2: 1x10mL EUDAMED3011484 EUDAMEDR1: 1x20mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3011816 EUDAMEDR1: 1x20mL, R2: 1x10mL， Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3012875 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202247033 EUDAMED06942202247040 EUDAMED06942202239212 EUDAMED
- Basic UDI-DI
- B-06942202247033 EUDAMEDB-06942202247040 EUDAMEDB-06942202239212 EUDAMED
- EMDN Code
- W01010121 LACTATE DEHYDROGENASE ISOENZYMES 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
Lactate Dehydrogenase Isoenzyme 1 Reagent Kit (Chemical Inhibition 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-06942202247033 | 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 49748c26-b89c-4cc3-9313-4d4eaceadee5 61 fields · synced Jul 26, 2026
- EUDAMED 9cb6a791-ab9b-4636-b4b4-300322c2bb0f 61 fields · synced May 18, 2026
- EUDAMED c6bffe07-681f-4f07-8760-0c75b8f8aa77 61 fields · synced Jul 11, 2026