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Heart Fatty Acid-Binding Protein Reagent Kit (Latex Immunoturbidimetric Assay)
EUDAMEDClass IVD General (EU MDR)
Ref 3012812Model 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: 2x20mL, R2: 2x20mL, Calibration sample: 6x0.5mL, Control: 2x0.5mL EUDAMED3012812 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202260919 EUDAMED
- Basic UDI-DI
- B-06942202260919 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
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
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-06942202260919 | 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 (1)
- EUDAMED ae786d70-b8b9-463a-89f0-f3672ff111a5 61 fields · synced Jun 18, 2026