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D-Dimer Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref /
Identity
- Device Name
- D-Dimer Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-19074 EUDAMED
- Basic UDI-DI
- B-19074 EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
D-Dimer Assay Kit (Latex Immunoturbidimetric Method) by Shanghai Kehua Bio-engineering 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-19074 | 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 347be672-85c4-4bde-af2b-2b047b69177b 61 fields · synced Jul 28, 2026