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Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay)
EUDAMEDClass IVD General (EU MDR)
Ref R1: 2×5mL; R2: 1×2mL; OVB Buffer: 1×51 mL; Calibrator: 1×1mL; Control:1×1mL
Identity
- Device Name
- Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) EUDAMED
- Model / Reference
- R1: 2×5mL; R2: 1×2mL; OVB Buffer: 1×51 mL; Calibrator: 1×1mL; Control:1×1mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942202234668 EUDAMED
- Basic UDI-DI
- B-06942202234668 EUDAMED
- EMDN Code
- W0103020307 THROMBIN-ANTITHROMBIN III-COMPLEX EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria 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
Antithrombin Ⅲ Detection Kit (Chromogenic Substrate Assay) by Dirui Industrial 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-06942202234668 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Dirui Industrial Co., Ltd
- EUDAMED SRN
- CN-MF-000001891
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 3aceafb1-11fb-4543-ad61-185e8de1565b 61 fields · synced Jun 19, 2026
- EUDAMED 3aceafb1-11fb-4543-ad61-185e8de1565b-1 61 fields · synced Jun 9, 2026