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Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immu…

EUDAMED

Class IVD General (EU MDR)

Ref 25 Tests/KitRef 50 Tests/KitRef R1:20mL×4 R2:20mL×4（709）Ref R1:20mL×1 R2:20mL×1（702）Ref R1:50mL×1 R2:50mL×1（701）Ref 69543760F000626FModel 100 Tests

by Wuhan Life Origin Biotech Joint Stock Co., Ltd.

Identity

Trade Name
Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit （Latex Immunoturbidimetric） EUDAMED
Heart-type Fatty Acid Binding Protein（H-FABP）Assay Kit EUDAMED
Device Name
Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immunoassay) EUDAMED
Heart-type Fatty Acid-Binding Protein (H-FABP) Assay Kit （Latex Immunoturbidimetric） EUDAMED
Heart-type Fatty Acid Binding Protein（H-FABP）Assay Kit EUDAMED
Model / Reference
25 Tests/Kit EUDAMED
50 Tests/Kit EUDAMED
R1:20mL×4 R2:20mL×4（709） EUDAMED
R1:20mL×1 R2:20mL×1（702） EUDAMED
R1:50mL×1 R2:50mL×1（701） EUDAMED
100 Tests EUDAMED
69543760F000626F EUDAMED

Identifiers

Primary DI / UDI-DI
06974986814569 EUDAMED
06974986814576 EUDAMED
06971674869863 EUDAMED
06971674869870 EUDAMED
06971674869856 EUDAMED
06954376005456 EUDAMED
Basic UDI-DI
B-06974986814569 EUDAMED
B-06974986814576 EUDAMED
B-06971674869863 EUDAMED
B-06971674869870 EUDAMED
B-06971674869856 EUDAMED
B-06954376005456 EUDAMED
EMDN Code
W01021302 HEART-TYPE FATTY ACID BINDING PROTEIN EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMEDEUDAMED

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 (H-FABP) Assay Kit (Chemiluminescent Immu… by Wuhan Life Origin Biotech Joint Stock Co., Ltd. — Class IVD General — IVDD…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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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 (6)

  • EUDAMED 677e0d0a-170b-474e-8350-305e48b0931d 61 fields · synced Oct 7, 2026
  • EUDAMED c6053ed7-ad1f-44e5-9069-ea930bfc4f22 61 fields · synced May 17, 2026
  • EUDAMED 095dda5a-a198-4273-acbd-e7bef18b8c15 61 fields · synced May 17, 2026
  • EUDAMED 98c950dd-f822-4a75-8f06-dedf6ef3cd2e 61 fields · synced May 17, 2026
  • EUDAMED 1c3093a6-df2a-4839-98f3-4a3d2b35dc27 61 fields · synced May 18, 2026
  • EUDAMED cde9d131-9fb1-463b-9a7d-79f90ccbad4a 61 fields · synced May 18, 2026