Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019737388

FEI Number

3019737388

Entity Name

Hangzhou VivaLNK Medical Technology Co.,LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

Room 502, Floor 5, Building 2, No.2, 8th Avenue, Baiyang Sub-district, Qiantang District,, Hangzhou Zhejiang 310000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

VivaLnk Inc (Owner Number: 10049171)

Owner / Operator Contact Address

51 EAST CAMPBELL AVE., SUITE 160, Campbell, CA 95008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Checkme O2/SpO2oxiband sleepmonitor VV330 Continuous ECG Platform VV330 Continuous ECG Recorder VV350 Continuous ECG Platform VV350 Continuous ECG Recorder VV360 Continuous ECG Recorder VV360 Continuous ECG Platform Fever Scout Continuos monitoring thermometer Continuos monitoring thermometer Continuos monitoring thermometer - VV200 Temperature Adhesive Disposable Hydrogel Adhesive Fever Scout Adhesive Hydrogel Adhesive VivaLNK Adhesive Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-01-04
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2020-01-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-02-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-07-23

Official Correspondent

quoi huynh

US Agent Details

quoi huynh Business: VIVALNK INC Email: qh@vivaLnk.com Phone: (408) 8682898

Related Public Records

Same Entity

VivaLnk Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3022331717	Shenzhen Omori Biological Technology Co., Ltd.	Shenzhen city Guangdong, CN
3017643152	Dongguan CFE Electronic Co., Ltd	Dongguan Guangdong, CN
3011651103	VIVALNK, INC.	Campbell, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3014652024	CEA GROUP INTERNATIONAL CO.,LTD	Wenzhou Zhejiang, CN
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019737388. Last updated year: 2026. Please use registration number 3019737388 when referencing this establishment in official correspondence.