← Back to catalogue
Prothrombin Time Assay Reagent (Coagulation Method)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0002-01Model CA-PT：4.0 mL×10
Identity
- Trade Name
- Prothrombin Time Assay Reagent (Coagulation Method) EUDAMED
- Device Name
- Prothrombin Time Assay Reagent (Coagulation Method) EUDAMED
- Model / Reference
- CA-PT：4.0 mL×10 EUDAMEDNX-0002-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451025 EUDAMED
- Basic UDI-DI
- B-06976117451025 EUDAMED
- EMDN Code
- W0103020101 PROTHROMBIN TIME ( QUICK TEST ) 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
Prothrombin Time Assay Reagent (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-06976117451025 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dymind Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024842
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 4db68641-b18b-4344-8ad4-75dd98f37653 61 fields · synced Oct 5, 2026