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Cholesterol Reagent Kit（enzyme Method）
EUDAMEDClass IVD General (EU MDR)
Ref 3000688Model R1: 4x80mL, R2: 4x20mL, Calibration sample: 2mLRef 3000690Model R1: 2x60mL, R2: 2x15mL, Calibration sample: 2mLRef 3023225Model R1: 4x50mL, R2: 2x25mL，Calibration sample: 2mLRef 3019370Model R1: 2L, R2: 500mL，Calibration sample: 20mLRef 3021657Ref 3016531Model R1: 4x50mL, R2: 1x50mL，Calibration sample: 2mL
Identity
- Trade Name
- CHOLESTEROL REAGENT KIT（ENZYME METHOD） EUDAMED
- Device Name
- CHOLESTEROL REAGENT KIT（ENZYME METHOD） EUDAMED
- Model / Reference
- R1: 4x80mL, R2: 4x20mL, Calibration sample: 2mL EUDAMED3000688 EUDAMEDR1: 2x60mL, R2: 2x15mL, Calibration sample: 2mL EUDAMED3000690 EUDAMEDR1: 4x50mL, R2: 2x25mL，Calibration sample: 2mL EUDAMED3023225 EUDAMEDR1: 2L, R2: 500mL，Calibration sample: 20mL EUDAMED3019370 EUDAMED3021657 EUDAMEDR1: 4x50mL, R2: 1x50mL，Calibration sample: 2mL EUDAMED3016531 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260964 EUDAMED06942202260926 EUDAMED06942202213366 EUDAMED06925794581259 EUDAMED06925794592361 EUDAMED06942202260957 EUDAMED
- Basic UDI-DI
- B-06942202260964 EUDAMEDB-06942202260926 EUDAMEDB-06942202213366 EUDAMEDB-06925794581259 EUDAMEDB-06925794592361 EUDAMEDB-06942202260957 EUDAMED
- EMDN Code
- W01010205 CHOLESTEROL 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
Category: Total cholesterol lipid IVD, reagent
Cholesterol Reagent Kit（enzyme Method） by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Total cholesterol lipid IVD, reagent.
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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-06942202260964 | 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 c3947f1e-e4a8-482d-b66a-9e8745ec9c16 61 fields · synced Sep 17, 2026
- EUDAMED 05147b16-d9d3-4dee-a9c1-9d0bd1fad86a 61 fields · synced May 18, 2026
- EUDAMED 3e3c0d1c-bdb5-4697-8642-71869ea4453f 61 fields · synced Jul 16, 2026
- EUDAMED d5190deb-1390-4e4e-b7c1-ff9c56d6c331 61 fields · synced Jul 17, 2026
- EUDAMED a55d21bd-e4d9-4f0e-bd0a-46fa72331ea7 61 fields · synced Jul 19, 2026
- EUDAMED 1b2f9276-991d-4a0c-8d49-4cc69368bdc4 61 fields · synced Jul 30, 2026