Fingertip Pulse Oximeter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref YK-81A

by Xuzhou Yongkang Electronic Science Technology Co., Ltd.

Identity

Trade Name: Fingertip Pulse Oximeter EUDAMED
yonker FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: Fingertip Pulse Oximeter EUDAMEDFDA UDI
Model / Reference: YK-81A EUDAMED
YK-83 FDA UDI
Description: Fingertip Pulse Oximeter FDA UDI

Identifiers

Primary DI / UDI-DI: 06921745200033 EUDAMEDFDA UDI
Basic UDI-DI: 69217452FPO2V EUDAMED
Direct Marketing DI: 06921745200033 EUDAMED
FDA Product Code: OCH 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: 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

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 54dd51ec-f34d-4d38-b1c2-9f5c380e623d 61 fields · synced Oct 6, 2026
FDA UDI ddd0d8d0-8437-492f-bd89-c85db42ae78a 33 fields · synced May 30, 2026