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Clotting Tetrachoric Combined Testing Kit (Coagulation Method)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0030-05Model CA (PT+APTT) Specification 1: 1 test/kit
Identity
- Trade Name
- Clotting Tetrachoric Combined Testing Kit (Coagulation Method) EUDAMED
- Device Name
- Clotting Tetrachoric Combined Testing Kit (Coagulation Method) EUDAMED
- Model / Reference
- CA (PT+APTT) Specification 1: 1 test/kit EUDAMEDNX-0030-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451704 EUDAMED
- Basic UDI-DI
- B-06976117451704 EUDAMED
- EMDN Code
- W01030299 HAEMOSTASIS REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Clotting Tetrachoric Combined Testing Kit (Coagulation Method) 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-06976117451704 | 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 (1)
- EUDAMED 677f97a4-d88e-4a93-9ff3-5c2e32dfddf6 61 fields · synced Jun 18, 2026