YUWELL® Finger Pulse Oximeter

by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. 3 variants

Ref YX301, YX105, YX310, YX110, YX310 (REF YX310001), YX110 (REF YX110001)510(k) K212385Model YX105,YX106, YX102, YX105, YX106, YX110,YX301, YX306, YX310

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212385↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number06933257921979 UDI-DI	Date6 May 2026Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number693325792197JJ Basic UDI-DI	Date23 Apr 2026Registered	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK212385	Date16 Aug 2022Cleared	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

United States FDA 510(k) Active
European Union CE/MDR Active

EU market availability

Made available in 3 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

Italy since 1 Apr 2024
Romania since 1 Apr 2024
Slovakia since 1 Apr 2024

Last checked 24 Oct 2026.

Specification

EUDAMED · 510(k) · GUDID

Generic Name: Pulse oximeter
Device Name: Finger Pulse Oximeter
Model / Reference: YX301, YX105, YX106, YX310, YX110, YX102, YX306, YX310 (REF YX310001), YX110 (REF YX110001)

Primary DI / UDI-DI: 06933257921979, 06933257923171, 06933257922013, 06933257922006
Basic UDI-DI: 693325792197JJ, 693325792317J4, 693325792201HG, 693325792200HE, 693325792194JC
Direct Marketing DI: 06933257921979
06933257923171
06933257922013
06933257922006
510(k) Number: K252805
FDA Product Code: DQA
EMDN Code: Z1203020408 Pulse oximeters
GMDN Term: Pulse oximeter

Device Class: Class IIa EUDAMED
Class II GUDID
Regulation Number: 870.2700
EU market of registration: Malta
Italy
Slovakia
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device Class	EUDAMED Class IIa	GUDID Class II

Manufacturer details

EUDAMED SRN: CN-MF-000012834
Authorised representative: Metrax GmbH DE-AR-000005481

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Class IIa
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Class IIb
YUWELL® Finger Pulse Oximeter

Class IIa
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Class IIa
Nebulizing Mesh

Class I
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See all devices from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. →

Properties

Measuring Function
Prescription Use
Lot / Batch Number
Serial Number
Expiration Date

Other properties (19)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Manufacturing Date: No