Blue D-Dimer LC
by TECO Medical Instruments, Production + Trading GmbH Germany EUDAMED
Ref D2020-005
EMDN W0103020503
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-DD-D2020-0057E | Date16 Aug 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Dd
- Model / Reference
- D2020-005
- Primary DI / UDI-DI
- D-DD-D2020-0057E
- Basic UDI-DI
- B-DD-D2020-0057E
- EMDN Code
- W0103020503 D-dimer
- Device Class
- Class IVD General
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000022642
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Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED abfd3d7b-6ad6-4f1a-a36f-1f9e0fec7456