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Fibrin and Fibrinogen Degradation Products Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref NX-0014-01Model CAL-FDP,Calibrator 1: 1 × 1.0 mL，Calibrator 2: 1 ×1.0 mL，Calibrator 3: 1 × 1.0 mL，Calibrator 4: 1 × 1.0 mL，Calibrator 5: 1 × 1.0 Ml Ref NX-0014-03Model CAL-FDP，Calibrator 5: 1 × 1.0 mL
Identity
- Trade Name
- Fibrin and Fibrinogen Degradation Products Calibrator EUDAMED
- Device Name
- Fibrin and Fibrinogen Degradation Products Calibrator EUDAMED
- Model / Reference
- CAL-FDP,Calibrator 1: 1 × 1.0 mL，Calibrator 2: 1 ×1.0 mL，Calibrator 3: 1 × 1.0 mL，Calibrator 4: 1 × 1.0 mL，Calibrator 5: 1 × 1.0 Ml EUDAMEDNX-0014-01 EUDAMEDCAL-FDP，Calibrator 5: 1 × 1.0 mL EUDAMEDNX-0014-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117454514 EUDAMED06941377300260 EUDAMED
- Basic UDI-DI
- B-06976117454514 EUDAMEDB-06941377300260 EUDAMED
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS 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
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
Fibrin and Fibrinogen Degradation Products Calibrator by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06976117454514 | 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 (2)
- EUDAMED 4be9a33e-3d25-4109-b821-a3528cf71375 61 fields · synced Jul 16, 2026
- EUDAMED 99e7cb6b-6c2b-4515-b2f3-9edf895a3401 61 fields · synced May 17, 2026