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Semi-auto Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref NX-0040-02Model DC1040、DC1041、DC1020、DC1021Ref NX-0040-04Ref NX-0040-01Ref NX-0040-03
Identity
- Trade Name
- Semi-auto Coagulation Analyzer EUDAMED
- Device Name
- Semi-auto Coagulation Analyzer EUDAMED
- Model / Reference
- DC1040、DC1041、DC1020、DC1021 EUDAMEDNX-0040-02 EUDAMEDNX-0040-04 EUDAMEDNX-0040-01 EUDAMEDNX-0040-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117455870 EUDAMED06976117456143 EUDAMED06976117455696 EUDAMED06976117456112 EUDAMED
- Basic UDI-DI
- 697049309W02020000001A2 EUDAMED
- Direct Marketing DI
- 06976117455870 EUDAMED06976117456143 EUDAMED06976117455696 EUDAMED06976117456112 EUDAMED
- EMDN Code
- W0202020101 SEMI-AUTOMATED COAGULOMETERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Semi-auto Coagulation Analyzer by Shenzhen Dymind Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697049309W02020000001A2 | Class A | 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 d4cef689-a520-441c-ae6b-a3f03c5443d1 61 fields · synced Aug 2, 2026
- EUDAMED 4c4decc0-aaa0-4dfc-bcde-c1acc6b206a2 61 fields · synced May 17, 2026
- EUDAMED 50037586-b296-4dd7-af84-733c5d0295c6 61 fields · synced May 17, 2026
- EUDAMED 6cb4301a-2255-4779-a7cd-61e796ca973b 61 fields · synced May 19, 2026