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Automatic Coagulation Analyzer
EUDAMEDClass A (EU MDR)
Ref DM9102CA1205Model CA1200
Identity
- Trade Name
- Automatic Coagulation Analyzer EUDAMED
- Device Name
- Automatic Coagulation Analyzer EUDAMED
- Model / Reference
- CA1200 EUDAMEDDM9102CA1205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976117458178 EUDAMED
- Basic UDI-DI
- 6970493090802006PE EUDAMED
- EMDN Code
- W0202020102 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic 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 | 6970493090802006PE | 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 (1)
- EUDAMED bc7b1860-fd02-42b2-a7e9-65adc54d4d65 61 fields · synced Jun 19, 2026