← Back to catalogue
D-dimer Determination Kit (Fluorescence Immunochromatography)
EUDAMEDClass IVD General (EU MDR)
Ref 25tests/kit
Identity
- Trade Name
- D-dimer Determination Kit (Fluorescence Immunochromatography) EUDAMED
- Device Name
- D-dimer Determination Kit (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- 25tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974986811902 EUDAMED
- Basic UDI-DI
- B-06974986811902 EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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 Determination Kit (Fluorescence Immunochromatography) by Wuhan Life Origin Biotech Joint Stock 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-06974986811902 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
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 (1)
- EUDAMED 8c8a887f-5123-491a-82f8-f598670321cd 61 fields · synced Oct 7, 2026