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konsung

EUDAMED

Class IIa (EU MDR)

Ref 6120Model SONOSAT-K01R, SONOSAT-K02R, SONOSAT-K01SR, SONOSAT-K02SR, SONOSAT-K01W, SONOSAT-K02W, SONOSAT-K01SW, SONOSAT-K02SW, SONOSAT-K01T, SONOSAT-K02T, SONOSAT-K01LT, SONOSAT-K02LT, SONOSAT-K01P, SONOSAT-K02P, SONOSAT-K01LP, SONOSAT-K02LP

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

Identity

Trade Name
konsung EUDAMED
Device Name
Fingertip Pulse Oximeter EUDAMED
Model / Reference
SONOSAT-K01R, SONOSAT-K02R, SONOSAT-K01SR, SONOSAT-K02SR, SONOSAT-K01W, SONOSAT-K02W, SONOSAT-K01SW, SONOSAT-K02SW, SONOSAT-K01T, SONOSAT-K02T, SONOSAT-K01LT, SONOSAT-K02LT, SONOSAT-K01P, SONOSAT-K02P, SONOSAT-K01LP, SONOSAT-K02LP EUDAMED
6120 EUDAMED

Identifiers

Primary DI / UDI-DI
06934822531111 EUDAMED
Basic UDI-DI
693482256120HL EUDAMED
EMDN Code
Z1203020408 PULSE OXIMETERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

konsung by Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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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 (1)

  • EUDAMED 43a7de4a-e138-465c-b2da-b7cbda460dbe 61 fields · synced May 23, 2026