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LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）
EUDAMEDClass IVD General (EU MDR)
Ref 3002328Model R1: 1x45mL, R2: 1x15mLRef 3003007Ref 3021727Model R1: 1x45mL, R2: 1x15mL,Calibration sample: 1mL,Ref 3005995Model Calibration sample: 1×1mLRef 3021156Model R1: 1x45mL, R2: 1x15mL,Calibration sample: 1mL
Identity
- Trade Name
- LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
- Device Name
- LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
- Model / Reference
- R1: 1x45mL, R2: 1x15mL EUDAMED3002328 EUDAMED3003007 EUDAMEDR1: 1x45mL, R2: 1x15mL,Calibration sample: 1mL, EUDAMED3021727 EUDAMEDCalibration sample: 1×1mL EUDAMED3005995 EUDAMEDR1: 1x45mL, R2: 1x15mL,Calibration sample: 1mL EUDAMED3021156 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202247170 EUDAMED06942202261220 EUDAMED06925794593740 EUDAMED06942202261787 EUDAMED06942202261237 EUDAMED
- Basic UDI-DI
- B-06942202247170 EUDAMEDB-06942202261220 EUDAMEDB-06925794593740 EUDAMEDB-06942202261787 EUDAMEDB-06942202261237 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
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
LIPOPROTEIN (a) REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC 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-06942202247170 | 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 bf1ac69b-6ac9-4de5-ac1d-065e2c493be5 61 fields · synced Jul 25, 2026
- EUDAMED 845edbee-f2a3-4f37-b2bb-93b7c0f3f17c 61 fields · synced May 18, 2026
- EUDAMED 1943e125-0c0d-414b-9d16-c003254b6729 61 fields · synced Jul 12, 2026
- EUDAMED a66c975b-38cc-4725-a70a-8c0f2dfddc52 61 fields · synced Jul 14, 2026
- EUDAMED bbb2f7b0-f23d-49c1-b8fe-0400f235097c 61 fields · synced Jul 25, 2026