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Compass3000-2
EUDAMEDClass A (EU MDR)
Ref Compass3000-2Model Compass3000-1, Compass3000-2
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Model / Reference
- Compass3000-1, Compass3000-2 EUDAMEDCompass3000-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535225 EUDAMED
- Basic UDI-DI
- 693482255902JK EUDAMED
- Direct Marketing DI
- 06934822535225 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Compass3000-2 by Jiangsu Konsung Bio-Medical Science And 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 | 693482255902JK | Class A | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000016839
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2b1616d0-ec3f-4453-aec6-fdf7e939447a 61 fields · synced Jun 19, 2026