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Antithrombin III Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref NX-0016-02Model CAL AT-III,1× 1.0 mL/kitRef NX-0016-01Model CAL AT-III,6× 1.0 mL/kitModel Model：CAL AT-III 6× 1.0 mL/kitModel Model：CAL AT-III 1× 1.0 mL/kit
Identity
- Trade Name
- Antithrombin III Calibrator EUDAMEDAntithrombin Ⅲ Calibrator EUDAMED
- Device Name
- Antithrombin III Calibrator EUDAMEDAntithrombin Ⅲ Calibrator EUDAMED
- Model / Reference
- CAL AT-III,1× 1.0 mL/kit EUDAMEDNX-0016-02 EUDAMEDCAL AT-III,6× 1.0 mL/kit EUDAMEDNX-0016-01 EUDAMEDModel：CAL AT-III 6× 1.0 mL/kit EUDAMEDModel：CAL AT-III 1× 1.0 mL/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377300307 EUDAMED06941377300314 EUDAMED
- Basic UDI-DI
- B-06941377300307 EUDAMEDB-06941377300314 EUDAMED
- EMDN Code
- W0103020701 CALIBRATION PLASMA FOR HAEMOSTASIS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
Antithrombin III Calibrator 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-06941377300307 | 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 6d866e19-9803-425a-947a-12ff0047ff15 61 fields · synced Oct 6, 2026
- EUDAMED e8b39396-db96-46e1-ba27-615ac0939cc4 61 fields · synced May 18, 2026
- EUDAMED bcc965f1-b1bf-40a4-9aa6-939ab2aad45c 61 fields · synced Jul 18, 2026
- EUDAMED dc7900b0-c86c-40ba-967c-7081114ed6c1 61 fields · synced Aug 2, 2026