Fingertip Pulse Oximeter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref YK-80C

by Xuzhou Yongkang Electronic Science Technology Co., Ltd.

Identity

Trade Name: yonker FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: Fingertip Pulse Oximeter EUDAMEDFDA UDI
Model / Reference: YK-80C EUDAMED
YK-81 FDA UDI
Description: Fingertip Pulse Oximeter FDA UDI

Identifiers

Primary DI / UDI-DI: 06921745200026 EUDAMEDFDA UDI
Basic UDI-DI: 69217452FPO2V EUDAMED
Direct Marketing DI: 06921745200026 EUDAMED
510(k) Number: K161938 FDA UDI
FDA Product Code: DQA FDA UDI
EMDN Code: Z1203020408 PULSE OXIMETERS EUDAMED
GMDN Term: Pulse oximeter FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
Market of Registration: Poland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Fingertip Pulse Oximeter by Xuzhou Yongkang Electronic Science Technology Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	69217452FPO2V	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Xuzhou Yongkang Electronic Science Technology Co., Ltd.
EUDAMED SRN: CN-MF-000018890
Authorised Representative: Prolinx GmbH DE-AR-000005129

Sources (2)

EUDAMED e7c119e7-281d-45e9-aece-9bc59cf21bdb 61 fields · synced Jun 19, 2026
FDA UDI 8ce2df38-7bfb-4d12-a8c8-9488c02a9db9 34 fields · synced May 30, 2026