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Patient Monitor

EUDAMED

Class IIa (EU MDR)

Ref 8100Model AURORA 10Model AURORA 8Model AURORA 12Model AURORA 10s

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

Identity

Device Name
Patient Monitor EUDAMED
Model / Reference
AURORA 10 EUDAMED
8100 EUDAMED
AURORA 8 EUDAMED
AURORA 12 EUDAMED
AURORA 10s EUDAMED

Identifiers

Primary DI / UDI-DI
06934822531401 EUDAMED
06934822531395 EUDAMED
06934822531418 EUDAMED
06934822531432 EUDAMED
Basic UDI-DI
B-06934822531401 EUDAMED
B-06934822531395 EUDAMED
B-06934822531418 EUDAMED
B-06934822531432 EUDAMED
EMDN Code
Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class IIb EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Patient Monitor by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
EUDAMED SRN
CN-MF-000016839
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED 3e3d593d-1f16-4ca8-99e8-b862f2df567f 61 fields · synced Oct 7, 2026
  • EUDAMED a7a4a161-5001-4e06-a499-cce0d6af4d70 61 fields · synced May 17, 2026
  • EUDAMED 5d4a7638-ac6f-4f69-b81e-dcf29bcd4904 61 fields · synced May 19, 2026
  • EUDAMED d5d12b58-783a-4ca5-871f-18af9b6248d0 61 fields · synced May 19, 2026