SHENZHEN VIATOM TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3011200896

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011200896
FEI Number
3011200896
Entity Name
SHENZHEN VIATOM TECHNOLOGY CO., LTD.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
Floor 3, Building 9, Baiwangxin Industrial Park, No.1002 Songbai Road, Yangguang Community, Xili Street, Nanshan District, Shenzhen Guangdong 518055, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Shenzhen Viatom Technology Co., Ltd. (Owner Number: 10050841)
Owner / Operator Contact Address
901, Building West, Lepu Tower, No.66 Xingke Road, Xili Community, Xili Street, Nanshan District, Shenzhen, CN-GD 518055, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Wireless Blood Pressure Monitor AirBP Blood Pressure Monitor Oxyfit Checkme Pro Health Monitor Checkme lite WEARO2 S13B SA-10BW S13 S6W S11 O2RING S8-AW SleepU S4 S12 S10 S9 Oxylink Oxiband-1 S14 S3 KidsO2 Babytone Sleep Sock (S1) Babytone Sleep Sock + (S1) Baby Sleep Monitor S1 Baby Sleep Monitor BabyO2 S2 Babytone Sleep Satview (S1) Baby Sleep Monitor BabyO2 Pulse Oximeter, Oxiband, Checkme O2 Wireless Probe Type Ultrasound Scanner

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-08-19
DQA Oximeter Cardiovascular Class 2 870.2700 2022-12-06
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2016-01-11
OCH Oximeter, Infrared, Sporting, Aviation Cardiovascular Class 2 870.2700 2023-06-28
PGJ Oximeter, Wellness Cardiovascular Class 2 870.2700 2018-11-11
DQA Oximeter Cardiovascular Class 2 870.2700 2019-12-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-12-06
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-12-06
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-12-06

Official Correspondent

Zhou Saixin

US Agent Details

Anny zhao Business: Hlongmed International Ltd. Email: usagent@hlongmed.com Phone: (503) 3344880

Related Public Records

Same Entity

Shenzhen Viatom Technology Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0020-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011200896. Last updated year: 2026. Please use registration number 3011200896 when referencing this establishment in official correspondence.
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