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D-Dimer (CLIA)
EUDAMEDClass IVD General (EU MDR)
Ref D-D706-AE10Y, D-D706-AE10N, D-D706-AE20Y, D-D706-AE20N
Identity
- Trade Name
- D-Dimer (CLIA) EUDAMED
- Device Name
- D-Dimer (CLIA) EUDAMED
- Model / Reference
- D-D706-AE10Y, D-D706-AE10N, D-D706-AE20Y, D-D706-AE20N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-D-D706-AE79 EUDAMED
- Basic UDI-DI
- B-D-D706-AE79 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 (CLIA) by Hangzhou Aichek 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-D-D706-AE79 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 9d0f1246-0c48-4c93-b2b0-36296215680f 61 fields · synced Jul 30, 2026
- EUDAMED 9d0f1246-0c48-4c93-b2b0-36296215680f-1 61 fields · synced Jun 10, 2026