Fingertip Pulse Oximeter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref K1

by Xuzhou Yongkang Electronic Science Technology Co., Ltd.

Identity

Trade Name: BRAUN FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: Fingertip Pulse Oximeter EUDAMED
The Braun Pulse oximeter (BPX801) is a non-sterile, reusable device intended for spot checking or intermittent determination of oxygen saturation in arterial blood, as well as the associated pulse rate by using the tip of the finger as the measurement site. The device is intended for adults 21 year of age or older, in a home-use environment (such as a home setting or places of business). FDA UDI
Model / Reference: K1 EUDAMED
BPX801US FDA UDI
Description: The Braun Pulse oximeter (BPX801) is a non-sterile, reusable device intended for spot checking or intermittent determination of oxygen saturation in arterial blood, as well as the associated pulse rate by using the tip of the finger as the measurement site. The device is intended for adults 21 year of age or older, in a home-use environment (such as a home setting or places of business). FDA UDI

Identifiers

Primary DI / UDI-DI: 06921745201191 EUDAMEDFDA UDI
Basic UDI-DI: B-06921745201191 EUDAMED
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: 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

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-06921745201191	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 51c5e964-14cd-458d-94c6-7526c68089da 61 fields · synced Oct 6, 2026
FDA UDI ec3afc26-c248-4509-8277-eae801b71d0e 33 fields · synced May 30, 2026