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Heart type fatty acid binding protein (H-FABP) Test Kit (Fluorescence Immunochr…

EUDAMED

Class IVD General (EU MDR)

Ref /Ref 50 tests / kit（DR009-2）Model 50 tests / kit

by Shenzhen Reetoo Biotechnology Co., Ltd

Identity

Trade Name
Heart-type Fatty Acid-Binding Protein (H-FABP) Test Kit (Fluorescence immunochromatography method) EUDAMED
Device Name
Heart type fatty acid binding protein (H-FABP) Test Kit (Fluorescence Immunochromatographic Assay) EUDAMED
Heart-type Fatty Acid-Binding Protein (H-FABP) Test Kit (Fluorescence immunochromatography method) EUDAMED
Model / Reference
/ EUDAMED
50 tests / kit EUDAMED
50 tests / kit（DR009-2） EUDAMED

Identifiers

Primary DI / UDI-DI
D-K90411-033PC EUDAMED
06976374750237 EUDAMED
Basic UDI-DI
B-K90411-033PC EUDAMED
B-06976374750237 EUDAMED
EMDN Code
W01021302 HEART-TYPE FATTY ACID BINDING PROTEIN EUDAMED
W0102160705 HEART-TYPE FATTY ACID-BINDING PROTEIN - RT & POC EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Italy EUDAMED
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMEDEUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Heart type fatty acid binding protein (H-FABP) Test Kit (Fluorescence Immunochr… by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Shenzhen Reetoo Biotechnology Co., Ltd
EUDAMED SRN
CN-MF-000011699
Authorised Representative
Umedwings Netherlands B.V. NL-AR-000000444

Sources (2)

  • EUDAMED e132ed01-9fd5-41f5-a87c-78499d5b325f 61 fields · synced Jul 16, 2026
  • EUDAMED 289cd575-a1a3-403c-a146-9225de312db7 61 fields · synced May 19, 2026