Wrist Pulse Oximeter

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 6200Model SONOSAT-W01T

by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.

Identity

Trade Name: konsung FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: Wrist Pulse Oximeter EUDAMED
This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer. FDA UDI
Model / Reference: SONOSAT-W01T EUDAMEDFDA UDI
6200 EUDAMED
Description: This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer. FDA UDI

Identifiers

Primary DI / UDI-DI: 06934822531296 EUDAMEDFDA UDI
Basic UDI-DI: B-06934822531296 EUDAMED
510(k) Number: K152089 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: Belgium 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

MRI Safety

MR Unsafe FDA UDI

Wrist Pulse Oximeter by Jiangsu Konsung Bio-Medical Science And 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-06934822531296	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
EUDAMED SRN: CN-MF-000016839
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED 8280e6c4-d086-465c-aa76-1df16701311f 61 fields · synced Jul 8, 2026
FDA UDI 65e2b198-0928-4302-909a-665e631ae90b 34 fields · synced May 30, 2026