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Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immu…
EUDAMEDClass IVD General (EU MDR)
Ref 100 Tests/KitRef 25 testsModel 25 tests，50 tests，2×50 tests，100 tests，2×100 testsRef 2×100 testRef 100 tests
Identity
- Trade Name
- Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immunoassay) EUDAMEDHeart-type Fatty Acid-Binding Protein Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
- Device Name
- Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immunoassay) EUDAMEDTotal Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method） EUDAMED
- Model / Reference
- 100 Tests/Kit EUDAMED25 tests，50 tests，2×50 tests，100 tests，2×100 tests EUDAMED25 tests EUDAMED2×100 test EUDAMED100 tests EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986814583 EUDAMED06978465237153 EUDAMED06978465232653 EUDAMED06978465237177 EUDAMED
- Basic UDI-DI
- B-06974986814583 EUDAMED697846523ProteinC15RQ EUDAMED
- EMDN Code
- W01021302 HEART-TYPE FATTY ACID BINDING PROTEIN EUDAMEDW0102160705 HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
New Device
No
EUDAMED
Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immu… by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06974986814583 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06974986814583 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Life Origin Biotech Joint Stock Co., Ltd.
- EUDAMED SRN
- CN-MF-000027340
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 55d04bd6-a220-48f3-9f9d-8402d25d96e2 61 fields · synced Oct 6, 2026
- EUDAMED 316e9291-bb90-4651-9e5c-a866f3fb78c1 61 fields · synced Jul 9, 2026
- EUDAMED e27564dd-67a6-41e2-9998-90f7bf4c1a8b 61 fields · synced Jul 9, 2026
- EUDAMED 77b6ef5b-ce90-4f59-a505-421bcb63c0fd 61 fields · synced Jul 14, 2026