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Anti-Xa Testing Kit(Chromogenic Assay)
EUDAMEDClass IVD General (EU MDR)
Ref NX-0029-05 Model CA Anti-Xa Specification 2 ：R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL
Identity
- Trade Name
- Anti-Xa Testing Kit(Chromogenic Assay) EUDAMED
- Device Name
- Anti-Xa Testing Kit(Chromogenic Assay) EUDAMED
- Model / Reference
- CA Anti-Xa Specification 2 ：R1: 4 × 4.0 mL, R2: 4 × 4.0 mL, R3: 4 × 2.0 mL EUDAMEDNX-0029-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377306545 EUDAMED
- Basic UDI-DI
- B-06941377306545 EUDAMED
- EMDN Code
- W0103020309 ANTI XA ACTIVITY FOR HEPARIN AND DOAC 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
Anti-Xa Testing Kit(Chromogenic Assay) by Shenzhen Dymind Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06941377306545 | 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 e3b3b3bb-d6bb-437b-bd4d-efadfb31da9c 61 fields · synced Jul 16, 2026