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Fully automated sample processing system
EUDAMEDClass A (EU MDR)
Ref DTS 800Ref Milestone 2
Identity
- Trade Name
- Fully automated sample processing system EUDAMED
- Device Name
- Fully automated sample processing system EUDAMED
- Model / Reference
- DTS 800 EUDAMEDMilestone 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976704971028 EUDAMED06976704971011 EUDAMED
- Basic UDI-DI
- 697670497102PC EUDAMED697670497101PA EUDAMED
- Direct Marketing DI
- 06976704971028 EUDAMED06976704971011 EUDAMED
- EMDN Code
- W02020199 CELL COUNTING INSTRUMENTS - OTHER 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
Fully automated sample processing system by Changchun Sunostik Medical Technology 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 | 697670497102PC | Class A | Active |
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Manufacturer
- Manufacturer
- Changchun Sunostik Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000051464
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED df9a1a8a-de20-4113-82e8-152dc74d0dcc 61 fields · synced Jul 9, 2026
- EUDAMED 792617d3-02e1-4838-84d8-071edce0c3ef 61 fields · synced May 19, 2026