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Antithrombin III Control
EUDAMEDClass IVD General (EU MDR)
Ref NX-0017-01Model CTRL-AT III,10 × 1.0 mL (low value)Ref NX-0017-04Model CTRL-AT III：1×1.0mL (high value)Ref NX-0017-03Model CTRL-AT III：1×1.0mL (low value)Ref NX-0017-02Model CTRL-AT III,10 × 1.0 mL (high value)
Identity
- Trade Name
- Antithrombin III Control EUDAMED
- Device Name
- Antithrombin III Control EUDAMED
- Model / Reference
- CTRL-AT III,10 × 1.0 mL (low value) EUDAMEDNX-0017-01 EUDAMEDCTRL-AT III：1×1.0mL (high value) EUDAMEDNX-0017-04 EUDAMEDCTRL-AT III：1×1.0mL (low value) EUDAMEDNX-0017-03 EUDAMEDCTRL-AT III,10 × 1.0 mL (high value) EUDAMEDNX-0017-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117454699 EUDAMED06941377305937 EUDAMED06941377305920 EUDAMED06976117454705 EUDAMED
- Basic UDI-DI
- B-06976117454699 EUDAMEDB-06941377305937 EUDAMEDB-06941377305920 EUDAMEDB-06976117454705 EUDAMED
- EMDN Code
- W0103020702 CONTROL PLASMA FOR HAEMOSTASIS 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
Antithrombin III Control 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-06976117454699 | 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 d7ff4355-31b1-4de6-b094-dbc2e534d11c 61 fields · synced Oct 6, 2026
- EUDAMED 8c605fb2-b347-48d4-be1c-971eda6e394b 61 fields · synced May 17, 2026
- EUDAMED 77d4efed-ec30-4574-8a20-e5ee525dc47d 61 fields · synced May 17, 2026
- EUDAMED 1136f773-acd7-4a51-9c2d-32bb256b4a9e 61 fields · synced May 19, 2026