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Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Metho…
EUDAMEDClass IVD General (EU MDR)
Ref NX-0043-03Model CA-APTT (EA) Specification 5 ：APTT reagent 1.0 mL × 10, CaCl2 solution 1.0 mL × 10
Identity
- Trade Name
- Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) EUDAMED
- Device Name
- Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Method) EUDAMED
- Model / Reference
- CA-APTT (EA) Specification 5 ：APTT reagent 1.0 mL × 10, CaCl2 solution 1.0 mL × 10 EUDAMEDNX-0043-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377306521 EUDAMED
- Basic UDI-DI
- B-06941377306521 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
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
Activated Partial Thromboplastin Time Assay Kit(Ellagic Acid)(Coagulation Metho… by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD…
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-06941377306521 | 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 89639c07-6eb8-4ad9-8f52-d96a7e9c9639 61 fields · synced Aug 4, 2026