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Thrombin Time Assay Reagent (Coagulation Method)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0004-01Model CA-TT：5.0 mL× 10Ref NX-0004-03Model CA-TT 3.0 mL×10Ref NX-0004-04Model CA-TT 1.5 mL×10Ref NX-0004-07Model CA-TT 15 tests/kitRef NX-0004-06Model CA-TT 10 tests/kitRef NX-0004-02Model CA-TT 3.0 mL× 1Ref NX-0004-08Model CA-TT 30 tests/kit
Identity
- Trade Name
- Thrombin Time Assay Reagent (Coagulation Method) EUDAMEDThrombin Time Assay Reagent（Coagulation Method） EUDAMED
- Device Name
- Thrombin Time Assay Reagent (Coagulation Method) EUDAMEDThrombin Time Assay Reagent（Coagulation Method） EUDAMED
- Model / Reference
- CA-TT：5.0 mL× 10 EUDAMEDNX-0004-01 EUDAMEDCA-TT 3.0 mL×10 EUDAMEDNX-0004-03 EUDAMEDCA-TT 1.5 mL×10 EUDAMEDNX-0004-04 EUDAMEDCA-TT 15 tests/kit EUDAMEDNX-0004-07 EUDAMEDCA-TT 10 tests/kit EUDAMEDNX-0004-06 EUDAMEDCA-TT 3.0 mL× 1 EUDAMEDNX-0004-02 EUDAMEDCA-TT 30 tests/kit EUDAMEDNX-0004-08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117451216 EUDAMED06976117451230 EUDAMED06976117451247 EUDAMED06976117451278 EUDAMED06976117451261 EUDAMED06976117451223 EUDAMED06976117451285 EUDAMED
- Basic UDI-DI
- B-06976117451216 EUDAMEDB-06976117451230 EUDAMEDB-06976117451247 EUDAMEDB-06976117451278 EUDAMEDB-06976117451261 EUDAMEDB-06976117451223 EUDAMEDB-06976117451285 EUDAMED
- EMDN Code
- W0103020103 THROMBIN TIME / REPTILASE / BATROXOBIN TIME 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
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
Thrombin 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-06976117451216 | 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 (7)
- EUDAMED d457eac1-b81c-41fc-8182-3b9ce60a842a 61 fields · synced Oct 6, 2026
- EUDAMED a296162f-405e-413d-adbe-243f62dc016e 61 fields · synced May 17, 2026
- EUDAMED 07387051-f2fd-4209-a5cc-0304c2241421 61 fields · synced May 18, 2026
- EUDAMED 7034c53f-c0d8-4ffd-99c6-553ac5aa5e42 61 fields · synced Jul 15, 2026
- EUDAMED 5f66468c-7cda-4d78-b5bf-da416e62297f 61 fields · synced Jul 16, 2026
- EUDAMED 2a6951c0-7acb-412a-b4ed-dac987f23512 61 fields · synced Aug 3, 2026
- EUDAMED d64917f4-cb41-42d1-b0d8-6494b743f083 61 fields · synced Sep 17, 2026