Finger Clip Pulse Oximeter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref YK-60B1

by Xuzhou Yongkang Electronic Science Technology Co., Ltd.

Identity

Trade Name: Finger Clip Pulse Oximeter EUDAMED
yonker FDA UDI
Generic Name: Infrared patient thermometer, ear FDA UDI
Device Name: Finger Clip Pluse Oximeter EUDAMED
Model / Reference: YK-60B1 EUDAMED
YK-IRT1 FDA UDI

Identifiers

Primary DI / UDI-DI: 06921745200170 EUDAMEDFDA UDI
Basic UDI-DI: 69217452FCPORQ EUDAMED
Direct Marketing DI: 06921745200170 EUDAMED
FDA Product Code: FLL FDA UDI
EMDN Code: Z1203020408 PULSE OXIMETERS EUDAMED
GMDN Term: Infrared patient thermometer, ear FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
Market of Registration: Germany 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Finger Clip 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	69217452FCPORQ	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 98132919-24bd-442e-95d3-4ef372eab0f7 61 fields · synced Oct 6, 2026
FDA UDI ba427508-131a-4956-a836-b4811e034061 32 fields · synced May 30, 2026