D-Dimer Control
by Wuhan Easydiagnosis Biomedicine Co., Ltd. EUDAMED
Active
Ref W-C-DD-1Model C1: 1*1 mL C2: 1*1 mL
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06978896415250 | Date15 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- C1: 1*1 mL C2: 1*1 mL, W-C-DD-1
- Primary DI / UDI-DI
- 06978896415250
- Basic UDI-DI
- B-06978896415250
- EMDN Code
- W0102152004 Cardiac marker controls
- Device Class
- Class IVD General
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CN-MF-000019908
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Wuhan Easydiagnosis Biomedicine Co., Ltd.
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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