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C-Reactive Protein Reagent Kit (latex Enhanced Immunoturbidimetric Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3009265Model R：2×25mL, Calibrator：5×0.5mL, Control：2×1mLRef 3009258Model R：1×25mLRef 3019475Model R1: 1.2L, R2: 300mL，Calibration sample: 10mLRef 3023236Model R1: 2x60mL, R2: 2x15mL,Ref 3001747Model R1: 1x40mL, R2: 1x10mL, Ref 3021174Model R1: 2x60mL, R2: 2x15mL, Calibration sample: 1mL,Ref 3021601Ref 3016504Ref 3016525Model R1: 2x60mL, R2: 2x15mL，Calibration sample: 1mL
Identity
- Trade Name
- C-REACTIVE PROTEIN REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY) EUDAMEDC-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
- Device Name
- C-REACTIVE PROTEIN REAGENT KIT (LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY) EUDAMEDC-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY） EUDAMED
- Model / Reference
- R：2×25mL, Calibrator：5×0.5mL, Control：2×1mL EUDAMED3009265 EUDAMEDR：1×25mL EUDAMED3009258 EUDAMEDR1: 1.2L, R2: 300mL，Calibration sample: 10mL EUDAMED3019475 EUDAMEDR1: 2x60mL, R2: 2x15mL, EUDAMED3023236 EUDAMEDR1: 1x40mL, R2: 1x10mL, EUDAMED3001747 EUDAMEDR1: 2x60mL, R2: 2x15mL, Calibration sample: 1mL, EUDAMED3021174 EUDAMED3021601 EUDAMED3016504 EUDAMEDR1: 2x60mL, R2: 2x15mL，Calibration sample: 1mL EUDAMED3016525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925794516367 EUDAMED06925794516909 EUDAMED06925794581228 EUDAMED06942202213007 EUDAMED06942202246760 EUDAMED06942202260063 EUDAMED06925794591937 EUDAMED06942202260056 EUDAMED06942202260049 EUDAMED
- Basic UDI-DI
- B-06925794516367 EUDAMEDB-06925794516909 EUDAMEDB-06925794581228 EUDAMEDB-06942202213007 EUDAMEDB-06942202246760 EUDAMEDB-06942202260063 EUDAMEDB-06925794591937 EUDAMEDB-06942202260056 EUDAMEDB-06942202260049 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE 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
C-Reactive Protein 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-06925794516367 | 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 (9)
- EUDAMED ee28359f-ec2f-4288-8b8d-988b19b5cfab 61 fields · synced Sep 18, 2026
- EUDAMED 80618a40-7e22-45a6-aa03-824a638c553b 61 fields · synced May 18, 2026
- EUDAMED d9dffb9f-7066-47c5-8acb-e1bed3563298 61 fields · synced Jul 10, 2026
- EUDAMED 18defd4e-e2e3-4af3-ad71-5e0a05285454 61 fields · synced Jul 10, 2026
- EUDAMED 30770a88-bb18-4148-8775-ac6a63838db2 61 fields · synced Jul 13, 2026
- EUDAMED 45a5a405-7c28-4a8a-ace2-cb8d61d9c95a 61 fields · synced Jul 15, 2026
- EUDAMED 7afcf8a6-e7c7-458f-a0f9-ab915cc4e913 61 fields · synced Jul 16, 2026
- EUDAMED 86a0953d-fa91-41e7-8c96-4305909a9cf0 61 fields · synced Jul 21, 2026
- EUDAMED 01b44dec-d07e-469a-9122-eb576512518a 61 fields · synced Sep 18, 2026