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Compass2800-1
EUDAMEDClass A (EU MDR)
Ref Compass2800-1Model Compass2800-1, Compass2800-2
by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
Identity
- Model / Reference
- Compass2800-1, Compass2800-2 EUDAMEDCompass2800-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934822535560 EUDAMED
- Basic UDI-DI
- 693482255660JJ EUDAMED
- Direct Marketing DI
- 06934822535560 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
Compass2800-1 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 | 693482255660JJ | 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 f823fc3e-c206-4eec-9fc7-b55f5a8c3767 61 fields · synced Jun 18, 2026