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Phospholipid Reagent Kit (Choline Oxide Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3013019Model R1: 1x40mL, R2: 1x10mLRef 3021666Model R1: 1x40mL, R2: 1x10mL，Calibration sample:1x1mL, Control:1x1mL
Identity
- Trade Name
- Phospholipid Reagent Kit (Choline Oxide Assay) EUDAMED
- Device Name
- Phospholipid Reagent Kit (Choline Oxide Assay) EUDAMED
- Model / Reference
- R1: 1x40mL, R2: 1x10mL EUDAMED3013019 EUDAMEDR1: 1x40mL, R2: 1x10mL，Calibration sample:1x1mL, Control:1x1mL EUDAMED3021666 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202261121 EUDAMED06925794592798 EUDAMED
- Basic UDI-DI
- B-06942202261121 EUDAMEDB-06925794592798 EUDAMED
- EMDN Code
- W01010224 PHOSPHOLIPIDS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Phospholipid Reagent Kit (Choline Oxide Assay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06942202261121 | 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 (2)
- EUDAMED 131b0f6e-bfd9-4f47-9214-61d9ce6b3770 61 fields · synced Jul 25, 2026
- EUDAMED 552dfb8b-f6c8-495e-911d-365174ca4045 61 fields · synced Jul 25, 2026