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Oximeter

EUDAMED

Class IIa (EU MDR)

Ref JZK-303Model JZK-301,JZK-303, JZK-305, JZK-307

by ShenZhen ZhengKang Technology Co., Ltd.

Identity

Trade Name
Oximeter EUDAMED
Device Name
Oximeter EUDAMED
Model / Reference
JZK-301,JZK-303, JZK-305, JZK-307 EUDAMED
JZK-303 EUDAMED

Identifiers

Primary DI / UDI-DI
06922119300205 EUDAMED
Basic UDI-DI
69221193XSY EUDAMED
Direct Marketing DI
06922119300205 EUDAMED
EMDN Code
Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France 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

Oximeter by Shenzhen Zhengkang 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

EUDAMED SRN
CN-MF-000038997
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED 2f18f837-35f0-478a-a4e1-7074da6158d5 61 fields · synced May 23, 2026