Wellue

FDA UDI

Class II (US FDA UDI)

by Shenzhen Viatom Technology Co., Ltd.

Identity

Trade Name: Wellue FDA UDI
Generic Name: Electrocardiograph, home-use FDA UDI
Model / Reference: BP2 Blood Pressure Monitor FDA UDI

Identifiers

Primary DI / UDI-DI: 06934440100850 FDA UDI
510(k) Number: K193348 FDA UDI
FDA Product Code: DXN FDA UDI
DPS FDA UDI
GMDN Term: Electrocardiograph, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1130 FDA UDI
870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Electrocardiograph, home-use

Wellue by Shenzhen Viatom Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiograph, home-use.

ASSURE Wearable ECG — Kestra Medical Technologies, Inc. · Class II
Withings® — Withings SA · Class II
Withings® — Withings SA · Class II
AfibAlert / hom ecg+ — LOHMAN TECHNOLOGIES, LLC · Class II
QT ECG — QT Medical, Inc. · Class II
GEMS Mobile ECG — CardioComm Solutions, Inc · Class II
TelePatch Cardiac Monitor — MEDICOMP, INC. · Class II
KardiaMobile Card — AliveCor · Class II

Cleared under the same submission

K193348 also covers:

DaliaSense — Stethoai LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shenzhen Viatom Technology Co., Ltd.

Sources (1)

FDA UDI 3468b863-4369-4bb9-b72d-c40ae15a2fb0 33 fields · synced Jun 1, 2026