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Retinol-Binding protein Reagent Kit (Latex Enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3009839Model R1: 2x60mL, R2: 2x20mL, Control: 2x1mLRef 3012526Model R1: 2x60mL, R2: 2x20mLRef 3016174Ref 3009833Model R1: 2x60mL, R2: 2x20mL, Calibration sample: 1x1mL
Identity
- Trade Name
- Retinol-Binding protein Reagent Kit (Latex Enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Retinol-Binding protein Reagent Kit (Latex Enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 2x60mL, R2: 2x20mL, Control: 2x1mL EUDAMED3009839 EUDAMEDR1: 2x60mL, R2: 2x20mL EUDAMED3012526 EUDAMED3016174 EUDAMEDR1: 2x60mL, R2: 2x20mL, Calibration sample: 1x1mL EUDAMED3009833 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202259821 EUDAMED06942202259791 EUDAMED06942202259784 EUDAMED06942202259814 EUDAMED
- Basic UDI-DI
- B-06942202259821 EUDAMEDB-06942202259791 EUDAMEDB-06942202259784 EUDAMEDB-06942202259814 EUDAMED
- EMDN Code
- W0102010306 RETINOL BINDING PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
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
Retinol-Binding protein Reagent Kit (Latex Enhanced Immunoturbidimetric 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-06942202259821 | 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 (4)
- EUDAMED 0ea75710-ffb7-4a80-a06b-bf90172f21fb 61 fields · synced Jul 22, 2026
- EUDAMED 613a7b49-7cf3-4d3c-815a-12aceda05e42 61 fields · synced May 17, 2026
- EUDAMED 485b14a8-b33f-43ce-afd1-a474297e221a 61 fields · synced May 18, 2026
- EUDAMED f3d3622b-ff3e-4bd8-927a-4ddde18e4e06 61 fields · synced May 19, 2026