D-Dimer Assay Kit (Immunoturbidimetry)
by Shenzhen Dymind Biotechnology Co., Ltd. EUDAMED
Active
Ref NX-0005-08Model Model : CA D-Dimer Specification8:1 test/kit
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06941377300130 | Date3 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Model / Reference
- Model : CA D-Dimer Specification8:1 test/kit, NX-0005-08
- Primary DI / UDI-DI
- 06941377300130
- Basic UDI-DI
- B-06941377300130
- EMDN Code
- W0103020503 D-dimer
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000024842
- Authorised representative
- Eunitor GmbH DE-AR-000005081
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Properties
Show properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No