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Lactate Dehydrogenase Reagent Kit（the Substrate Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000789Model R1: 2x60mL, R2: 2x15mLRef 3000790Model R1: 4x50mL, R2: 2x25mLRef 3023255Ref 3016559Model R1: 4x50mL, R2: 1x50mLRef 3019373Model R1: 2L, R2: 500mLRef 3016529Ref 3023223
Identity
- Trade Name
- LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD） EUDAMED
- Device Name
- LACTATE DEHYDROGENASE REAGENT KIT（THE SUBSTRATE METHOD） EUDAMED
- Model / Reference
- R1: 2x60mL, R2: 2x15mL EUDAMED3000789 EUDAMEDR1: 4x50mL, R2: 2x25mL EUDAMED3000790 EUDAMED3023255 EUDAMEDR1: 4x50mL, R2: 1x50mL EUDAMED3016559 EUDAMEDR1: 2L, R2: 500mL EUDAMED3019373 EUDAMED3016529 EUDAMED3023223 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260773 EUDAMED06942202257445 EUDAMED06942202213243 EUDAMED06942202260780 EUDAMED06925794581198 EUDAMED06942202260797 EUDAMED06942202213250 EUDAMED
- Basic UDI-DI
- B-06942202260773 EUDAMEDB-06942202257445 EUDAMEDB-06942202213243 EUDAMEDB-06942202260780 EUDAMEDB-06925794581198 EUDAMEDB-06942202260797 EUDAMEDB-06942202213250 EUDAMED
- EMDN Code
- W01010119 LACTATE DEHYDROGENASE L (LDH - L --> P) 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
EUDAMEDEUDAMED
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 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-06942202260773 | 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 (7)
- EUDAMED 4621ab83-bd20-4f30-ae91-88d4ae68ee5c 61 fields · synced Jul 27, 2026
- EUDAMED 18ab7167-875e-4c35-93d4-dc2afb934c6f 61 fields · synced May 19, 2026
- EUDAMED 5b31a696-87fc-4a2c-a583-7aa1e1f869b6 61 fields · synced Jul 13, 2026
- EUDAMED 07769119-373d-48f7-a30a-168be0d70478 61 fields · synced Jul 17, 2026
- EUDAMED 4c172f53-449f-4aca-a068-85d8c28d4a79 61 fields · synced Jul 20, 2026
- EUDAMED d1dd4681-e247-483a-8b2a-62fed84ae83a 61 fields · synced Jul 20, 2026
- EUDAMED d3050558-b7ac-412b-be2f-5ed5a8089400 61 fields · synced Jul 27, 2026