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Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric …
EUDAMEDClass IVD General (EU MDR)
Ref 3019834Model R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL
Identity
- Trade Name
- Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay) EUDAMED
- Device Name
- Lipoprotein-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- R1: 1x40mL, R2: 1x10mL, Calibration sample: 1x1mL, Control: 2x1mL EUDAMED3019834 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794576972 EUDAMED
- Basic UDI-DI
- B-06925794576972 EUDAMED
- EMDN Code
- W01021312 LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2 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
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-Associated Phospholipase A2 Reagent Kit (Latex Immunoturbidimetric … 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-06925794576972 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 75bddf85-9e7b-4ed0-9c1d-03da0f9e817b 61 fields · synced Jul 21, 2026