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Heart-type Fatty Acid Binding Protein Assay Kit (Latex Immunoturbidimetric Meth…
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- Heart-type Fatty Acid Binding Protein Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-11H7S EUDAMED
- Basic UDI-DI
- B-11H7S EUDAMED
- EMDN Code
- W01021302 HEART-TYPE FATTY ACID BINDING PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Heart-type Fatty Acid Binding Protein Assay Kit (Latex Immunoturbidimetric Meth… by Shanghai Kehua Bio-engineering Co., Ltd. — Class IVD General — IVDD…
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-11H7S | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Kehua Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000026756
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 3d99ef36-b87a-4380-a148-bc29c85ea655 61 fields · synced Oct 6, 2026