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D-Dimer Test Kit (Fluorescence Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-OT101
Identity
- Trade Name
- D-Dimer Test Kit (Fluorescence Immunoassay) EUDAMED
- Device Name
- D-Dimer Test Kit (Fluorescence Immunoassay) EUDAMED
- Model / Reference
- HWTS-OT101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-000012807163080PS EUDAMED
- Basic UDI-DI
- B-000012807163080PS EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 Test Kit (Fluorescence Immunoassay) by Jiangsu Macro & Micro-Test Med-Tech 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-000012807163080PS | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 7d0841a6-998d-4478-af2f-b7797f6fb93d 61 fields · synced Jun 19, 2026