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Compass2800-2

EUDAMED

Class A (EU MDR)

Ref Compass2800-2Model Compass2800-1, Compass2800-2

by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.

Identity

Model / Reference
Compass2800-1, Compass2800-2 EUDAMED
Compass2800-2 EUDAMED

Identifiers

Primary DI / UDI-DI
06934822535577 EUDAMED
Basic UDI-DI
693482255660JJ EUDAMED
Direct Marketing DI
06934822535577 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

Compass2800-2 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

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Manufacturer

EUDAMED SRN
CN-MF-000016839
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED 2e32212a-96b6-43a6-a092-38ddd880cea3 61 fields · synced Jun 18, 2026