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Prothrombin Time Assay Reagent (Coagulation Method)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0002-02Model CA-PT 2.0 mL×10Ref NX-0002-04Model CA-PT 2.0 mL × 1Ref NX-0002-06Model CA-PT 10 tests/kitRef NX-0069-02Model CA-PT(TF) Specification 2: 2.0 mL × 10Ref NX-0002-08Model CA-PT 30 tests/kit
Identity
- Trade Name
- Prothrombin Time Assay Reagent (Coagulation Method) EUDAMED
- Device Name
- Prothrombin Time Assay Reagent (Coagulation Method) EUDAMED
- Model / Reference
- CA-PT 2.0 mL×10 EUDAMEDNX-0002-02 EUDAMEDCA-PT 2.0 mL × 1 EUDAMEDNX-0002-04 EUDAMEDCA-PT 10 tests/kit EUDAMEDNX-0002-06 EUDAMEDCA-PT(TF) Specification 2: 2.0 mL × 10 EUDAMEDNX-0069-02 EUDAMEDCA-PT 30 tests/kit EUDAMEDNX-0002-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451032 EUDAMED06976117451056 EUDAMED06976117451070 EUDAMED06941377305005 EUDAMED06941377300208 EUDAMED
- Basic UDI-DI
- B-06976117451032 EUDAMEDB-06976117451056 EUDAMEDB-06976117451070 EUDAMEDB-06941377305005 EUDAMEDB-06941377300208 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
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMEDEUDAMED
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-06976117451032 | 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 (5)
- EUDAMED 44d14348-318c-4928-b157-1f8fbdeb014f 61 fields · synced Oct 5, 2026
- EUDAMED a944393d-efba-4ca5-a653-2689081b18d1 61 fields · synced Jun 20, 2026
- EUDAMED 81bb6fe0-8cb3-48af-8e25-d2a6b78016c3 61 fields · synced Jul 9, 2026
- EUDAMED eb0b5b86-c55f-4c43-8d10-d3ef4ed37e27 61 fields · synced Jul 12, 2026
- EUDAMED 26a75951-bbc3-42d1-b59c-f624cfc532ff 61 fields · synced Jul 23, 2026