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Low Density Lipoprotein Cholesterol Reagent Kit（direct Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000741Model R1: 2x60mL, R2: 2x20mL, Calibration sample: 0.8mLRef 3021686Model R1: 3x50mL, R2: 2x25mL，Calibration sample: 0.8mLRef 3021181Ref 3023310Model Calibration sample: 0.8mL Ref 3023246
Identity
- Trade Name
- LOW DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD） EUDAMED
- Device Name
- LOW DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD） EUDAMED
- Model / Reference
- R1: 2x60mL, R2: 2x20mL, Calibration sample: 0.8mL EUDAMED3000741 EUDAMEDR1: 3x50mL, R2: 2x25mL，Calibration sample: 0.8mL EUDAMED3021686 EUDAMED3021181 EUDAMEDCalibration sample: 0.8mL EUDAMED3023310 EUDAMED3023246 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260971 EUDAMED06925794592385 EUDAMED06942202260988 EUDAMED06942202261749 EUDAMED06942202213465 EUDAMED
- Basic UDI-DI
- B-06942202260971 EUDAMEDB-06925794592385 EUDAMEDB-06942202260988 EUDAMEDB-06942202261749 EUDAMEDB-06942202213465 EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
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
Low Density Lipoprotein Cholesterol Reagent Kit（direct 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-06942202260971 | 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 (5)
- EUDAMED 03105cc5-5aca-4a46-9a2a-479bc5537109 61 fields · synced Jul 31, 2026
- EUDAMED c9a9b665-5b4f-49b5-a50c-e02cc4985b60 61 fields · synced Jul 9, 2026
- EUDAMED 33272e3e-d421-482f-ac2b-64095fc972ed 61 fields · synced Jul 17, 2026
- EUDAMED c45fbc2f-4ea0-4cf2-b046-18ad96fd509f 61 fields · synced Jul 17, 2026
- EUDAMED 544a710a-7477-495a-ba8e-040cd34f4e34 61 fields · synced Jul 31, 2026