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Compass2000-1
EUDAMEDClass A (EU MDR)
Ref Compass2000-1Model Compass2000-1, Compass2000-2
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Model / Reference
- Compass2000-1, Compass2000-2 EUDAMEDCompass2000-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535010 EUDAMED
- Basic UDI-DI
- 693482255600HY EUDAMED
- Direct Marketing DI
- 06934822535010 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Compass2000-1 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 | 693482255600HY | 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 da13d1e2-9773-4d66-a3fa-4b5242b8207b 61 fields · synced Jun 18, 2026