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Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3011827Model R1: 1x10mL, R2: 1x10mL, Calibration sample: 6x0.5mL, Control: 2x0.5mLRef 3011560Model R1: 1x10mL, R2: 1x10mLRef 3012859Model R1: 2x20mL, R2: 2x20mLRef 3011558Model R1: 2x20mL, R2: 2x20mL, Calibration sample: 6x0.5mL, Control: 2x0.5mLRef 3021725Ref 3021534Model R1: 1x10mL, R2: 1x10mL， Calibration sample: 6x0.5mL, Control: 2x0.5mLRef 3021616Model R1: 2x20mL, R2: 2x20mL， Calibration sample: 6x0.5mL, Control: 2x0.5mL
Identity
- Trade Name
- Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay) EUDAMED
- Device Name
- Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- R1: 1x10mL, R2: 1x10mL, Calibration sample: 6x0.5mL, Control: 2x0.5mL EUDAMED3011827 EUDAMEDR1: 1x10mL, R2: 1x10mL EUDAMED3011560 EUDAMEDR1: 2x20mL, R2: 2x20mL EUDAMED3012859 EUDAMEDR1: 2x20mL, R2: 2x20mL, Calibration sample: 6x0.5mL, Control: 2x0.5mL EUDAMED3011558 EUDAMED3021725 EUDAMEDR1: 1x10mL, R2: 1x10mL， Calibration sample: 6x0.5mL, Control: 2x0.5mL EUDAMED3021534 EUDAMEDR1: 2x20mL, R2: 2x20mL， Calibration sample: 6x0.5mL, Control: 2x0.5mL EUDAMED3021616 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202247194 EUDAMED06942202247187 EUDAMED06942202260902 EUDAMED06942202260889 EUDAMED06925794593528 EUDAMED06925794593535 EUDAMED06925794593511 EUDAMED
- Basic UDI-DI
- B-06942202247194 EUDAMEDB-06942202247187 EUDAMEDB-06942202260902 EUDAMEDB-06942202260889 EUDAMEDB-06925794593528 EUDAMEDB-06925794593535 EUDAMEDB-06925794593511 EUDAMED
- EMDN Code
- W01021302 HEART-TYPE FATTY ACID 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
Heart Fatty Acid-Binding Protein Reagent Kit (Latex 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-06942202247194 | 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 (7)
- EUDAMED 77d170d3-9c50-4a90-8905-5865dad0a027 61 fields · synced Aug 2, 2026
- EUDAMED ef6524a4-8e96-4c5a-bf33-5361c51f50b0 61 fields · synced May 17, 2026
- EUDAMED 54b24e97-ae61-484d-a6df-f6bf84bcf6a9 61 fields · synced May 17, 2026
- EUDAMED a66871f6-7a56-4b89-95d7-811c7f9ce7fe 61 fields · synced May 18, 2026
- EUDAMED 107a83b1-be76-4ad3-b7be-38fb613e87c9 61 fields · synced Jul 8, 2026
- EUDAMED 7e61760a-2b20-4385-af71-45d61f3fc1d1 61 fields · synced Jul 11, 2026
- EUDAMED 309ea21f-1295-4351-9b34-67cfe9b4501f 61 fields · synced Jul 15, 2026