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D-Dimer STAT (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320500301Model 50TRef 0320500304Model 2×100T
Identity
- Trade Name
- D-Dimer STAT (eCLIA) EUDAMED
- Device Name
- D-Dimer STAT (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320500301 EUDAMED2×100T EUDAMED0320500304 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341688042 EUDAMED06975984063034 EUDAMED
- Basic UDI-DI
- B-06970341688042 EUDAMEDB-06975984063034 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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 STAT (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06970341688042 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 64b5d587-f9e4-499b-9284-56f18b467895 61 fields · synced Jul 18, 2026
- EUDAMED 35df156d-80d1-428b-9566-64e624f21646 61 fields · synced May 18, 2026