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D-Dimer Assay Kit (Immunoturbidimetry)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0005-01Model CA D-Dimer：R2: 2.0 mL×4, R1: 4.0 mL×4Ref NX-0005-06Model Model : CA D-Dimer Specification6: 2.0 mL×4Ref NX-0005-08Model Model : CA D-Dimer Specification8:1 test/kit Ref NX-0005-04Model Model : CA D-Dimer Specification4:R2:1.0 mL×4,R1:4.0 mL×2 Ref NX-0005-02Model Model : CA D-Dimer Specification2:R2:4.0 mL×4,R1:4.0 mL×8 Ref NX-0005-05Model Model : CA D-Dimer Specification5:1.0 mL×4
Identity
- Trade Name
- D-Dimer Assay Kit (Immunoturbidimetry) EUDAMED
- Device Name
- D-Dimer Assay Kit (Immunoturbidimetry) EUDAMED
- Model / Reference
- CA D-Dimer：R2: 2.0 mL×4, R1: 4.0 mL×4 EUDAMEDNX-0005-01 EUDAMEDModel : CA D-Dimer Specification6: 2.0 mL×4 EUDAMEDNX-0005-06 EUDAMEDModel : CA D-Dimer Specification8:1 test/kit EUDAMEDNX-0005-08 EUDAMEDModel : CA D-Dimer Specification4:R2:1.0 mL×4,R1:4.0 mL×2 EUDAMEDNX-0005-04 EUDAMEDModel : CA D-Dimer Specification2:R2:4.0 mL×4,R1:4.0 mL×8 EUDAMEDNX-0005-02 EUDAMEDModel : CA D-Dimer Specification5:1.0 mL×4 EUDAMEDNX-0005-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451292 EUDAMED06976117451346 EUDAMED06941377300130 EUDAMED06976117451322 EUDAMED06941377300116 EUDAMED06976117451339 EUDAMED
- Basic UDI-DI
- B-06976117451292 EUDAMEDB-06976117451346 EUDAMEDB-06941377300130 EUDAMEDB-06976117451322 EUDAMEDB-06941377300116 EUDAMEDB-06976117451339 EUDAMED
- EMDN Code
- W0103020503 D-DIMER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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 Assay Kit (Immunoturbidimetry) by Shenzhen Dymind Biotechnology 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-06976117451292 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (6)
- EUDAMED 3be39704-82e8-4a0a-9f52-c66a186a1d7d 61 fields · synced Oct 6, 2026
- EUDAMED 2dc86414-df13-4dbf-a60c-27ca86aad392 61 fields · synced Jun 20, 2026
- EUDAMED 8316bf76-85ac-4740-a284-7722d6ebe196 61 fields · synced Jul 9, 2026
- EUDAMED 0cd1fab5-3f16-4d0d-847d-e604fc00c5e6 61 fields · synced Jul 11, 2026
- EUDAMED f7832178-3a84-4d7e-92b7-02d00cdd7a47 61 fields · synced Jul 16, 2026
- EUDAMED b363ca4a-618a-44db-9e81-9c1bf9826166 61 fields · synced Jul 17, 2026