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High Density Lipoprotein Cholesterol Reagent Kit（direct Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000724Model R1: 4x60mL, R2: 4x20mL, Calibration sample: 0.8mLRef 3019414Model R1: 1.5L, R2: 500mL，Calibration sample: 10x0.8mL,Ref 3019127Model Calibration sample: 0.8mL Ref 3023244Model R1: 3x50mL, R2: 2x25mL，Calibration sample: 0.8mLRef 3021192Ref 3016526
Identity
- Trade Name
- HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD） EUDAMEDHIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT EUDAMED
- Device Name
- HIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT（DIRECT METHOD） EUDAMEDHIGH DENSITY LIPOPROTEIN CHOLESTEROL REAGENT KIT EUDAMED
- Model / Reference
- R1: 4x60mL, R2: 4x20mL, Calibration sample: 0.8mL EUDAMED3000724 EUDAMEDR1: 1.5L, R2: 500mL，Calibration sample: 10x0.8mL, EUDAMED3019414 EUDAMEDCalibration sample: 0.8mL EUDAMED3019127 EUDAMEDR1: 3x50mL, R2: 2x25mL，Calibration sample: 0.8mL EUDAMED3023244 EUDAMED3021192 EUDAMED3016526 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261091 EUDAMED06925794581358 EUDAMED06942202261756 EUDAMED06942202213151 EUDAMED06942202261077 EUDAMED06942202261084 EUDAMED
- Basic UDI-DI
- B-06942202261091 EUDAMEDB-06925794581358 EUDAMEDB-06942202261756 EUDAMEDB-06942202213151 EUDAMEDB-06942202261077 EUDAMEDB-06942202261084 EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL 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
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
High 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-06942202261091 | 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 (6)
- EUDAMED 59ea713c-468e-4c2a-924c-f610ffb56046 61 fields · synced Jul 29, 2026
- EUDAMED 27adbfba-d791-49ed-9b83-de5b7bc63f93 61 fields · synced Jul 9, 2026
- EUDAMED b56712dc-ec80-4640-9f33-120ab3bb438e 61 fields · synced Jul 9, 2026
- EUDAMED 7da946cb-e2c7-4664-92e4-3541188b2f2b 61 fields · synced Jul 12, 2026
- EUDAMED 11fb1bd7-f5bf-4d22-9da3-afb10c01e235 61 fields · synced Jul 24, 2026
- EUDAMED c9cb66c8-49bd-401e-8d6f-812fe8ce562e 61 fields · synced Jul 29, 2026