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Coagulation control
EUDAMEDClass IVD General (EU MDR)
Ref NX-0010-02Model CTRL Coag Coagulation control (level 2) : 1 × 1.0 mLRef NX-0010-03Model CTRL Coag Coagulation control (level 1) : 10 × 1.0 mLRef NX-0010-01Model CTRL Coag Coagulation control (level 1) : 1 × 1.0 mLRef NX-0010-04Model CTRL Coag Coagulation control (level 2) : 10 × 1.0 mL
Identity
- Trade Name
- Coagulation control EUDAMED
- Device Name
- Coagulation control EUDAMED
- Model / Reference
- CTRL Coag Coagulation control (level 2) : 1 × 1.0 mL EUDAMEDNX-0010-02 EUDAMEDCTRL Coag Coagulation control (level 1) : 10 × 1.0 mL EUDAMEDNX-0010-03 EUDAMEDCTRL Coag Coagulation control (level 1) : 1 × 1.0 mL EUDAMEDNX-0010-01 EUDAMEDCTRL Coag Coagulation control (level 2) : 10 × 1.0 mL EUDAMEDNX-0010-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451438 EUDAMED06976117451445 EUDAMED06976117451421 EUDAMED06976117451452 EUDAMED
- Basic UDI-DI
- B-06976117451438 EUDAMEDB-06976117451445 EUDAMEDB-06976117451421 EUDAMEDB-06976117451452 EUDAMED
- EMDN Code
- W0103020702 CONTROL 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
Coagulation control 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-06976117451438 | 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 (4)
- EUDAMED 4e32ee8a-0db6-43a0-bb21-cf1d755ad9b5 61 fields · synced Oct 6, 2026
- EUDAMED d37d49f2-8c7d-4f7c-bdac-969b286b29a9 61 fields · synced May 17, 2026
- EUDAMED 56a2a046-d88e-4391-bda1-9dd144982b81 61 fields · synced May 17, 2026
- EUDAMED 9fd22bc5-3d0e-4318-8505-f984c8ac12fc 61 fields · synced May 19, 2026