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Activated Partial Thromboplastin Time Assay Kit (Coagulation Method )
EUDAMEDClass IVD General (EU MDR)
Ref NX-0001-01Model CA-APTT：R1:2.0mL×1,R2:2.0mL×1Ref NX-0001-06Model CA-APTT 1 test/kitRef NX-0001-09Model CA-APTT 30 tests/kitRef NX-0001-07Model CA-APTT 10 tests/kit
Identity
- Trade Name
- Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) EUDAMED
- Device Name
- Activated Partial Thromboplastin Time Assay Kit (Coagulation Method ) EUDAMED
- Model / Reference
- CA-APTT：R1:2.0mL×1,R2:2.0mL×1 EUDAMEDNX-0001-01 EUDAMEDCA-APTT 1 test/kit EUDAMEDNX-0001-06 EUDAMEDCA-APTT 30 tests/kit EUDAMEDNX-0001-09 EUDAMEDCA-APTT 10 tests/kit EUDAMEDNX-0001-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117450936 EUDAMED06976117450981 EUDAMED06976117451018 EUDAMED06976117450998 EUDAMED
- Basic UDI-DI
- B-06976117450936 EUDAMEDB-06976117450981 EUDAMEDB-06976117451018 EUDAMEDB-06976117450998 EUDAMED
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN 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
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
Activated Partial Thromboplastin Time Assay 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-06976117450936 | 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 7a2d8449-a253-41d0-938e-5689ec7d12a3 61 fields · synced Jul 20, 2026
- EUDAMED ece66fb7-c211-4487-a385-36c6979cbb6c 61 fields · synced May 16, 2026
- EUDAMED c9cb794b-3da0-47bd-8c33-aad9748622ac 61 fields · synced May 18, 2026
- EUDAMED fb6f23a6-bd8c-4622-b545-d851508fcb4f 61 fields · synced May 19, 2026