Identity
- Trade Name
- D-Dimer (CLIA) EUDAMED
- Device Name
- D-Dimer (CLIA) EUDAMED
- Model / Reference
- MCL02202E EUDAMEDMCL02201E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802603123 EUDAMED06926802603116 EUDAMED
- Basic UDI-DI
- B-06926802603123 EUDAMEDB-06926802603116 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
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 (CLIA) by Medcaptain Medical 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-06926802603123 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (2)
- EUDAMED 74487b63-6f0e-49d5-b522-4b825feb5b56 61 fields · synced Jul 28, 2026
- EUDAMED 5ae96739-9c6f-4411-803e-1c2765659a30 61 fields · synced May 19, 2026