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Unfractionated Heparin Control
EUDAMEDClass IVD General (EU MDR)
Ref NX-0031-06Model CTRL-UFH Specification 4 ：10 × 1.0 mL (high-level)
Identity
- Trade Name
- Unfractionated Heparin Control EUDAMED
- Device Name
- Unfractionated Heparin Control EUDAMED
- Model / Reference
- CTRL-UFH Specification 4 ：10 × 1.0 mL (high-level) EUDAMEDNX-0031-06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941377305074 EUDAMED
- Basic UDI-DI
- B-06941377305074 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
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
Unfractionated Heparin 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-06941377305074 | 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 a3750d3c-255e-4b89-bdda-3a5d3f12abc5 61 fields · synced Jul 26, 2026