Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017953405

FEI Number

3017953405

Entity Name

SHENZHEN HUAYAN E-COMMERCE CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

A803, 8th Floor, Block A, Rongde Times Square, Henggang Street, Longgang District, Shenzhen Guangdong 518115, CN

Establishment Type(s)

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

Owner / Operator

Shenzhen Huayan E-commerce Co., Ltd. (Owner Number: 10079753)

Owner / Operator Contact Address

A803, 8th Floor, Block A, Rongde Times Square, Henggang Street, Longgang District, Shenzhen, CN-GD 518115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201354

PMA Number

N/A

All Registered Proprietary Names

MKISCWEI 2 Face/face Evolution Skincare Device VCBB Nebulizer Machine Model WH01,WH03,WH05,WH06,WH07,WH09,WH10,NEB012,NB018,NB912,NB812,NB732,NB89 Blood Pressure Monitor MD3151 Self-adhesive Electrode Pads NEBULIZER, Model: CAN-B22394324, CAN-BEC-YK-N2, CAN-BEC-YK-N3, CAN-BC68003, CAN-BC68005, TZ-W13 Nebulizer Kit, Nebulizer Mask, Nebulizer Mask Kit, VCBB Nebulizer-DISPOSABLE HAND HELD NEBULIZER TENS& PMS Unit TENS & EMS Device, FM-B2403 Fingertip Pulse Oximeter YM101 Oximeter PC-60F Adhesive Electrode; Electrodes PADS Belifu Conductive Gel Micro-current facial cold and hot service (Model:TPML-100) TENS & PMS, Model SM9079, SM9126, SM9186, SM9196

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2025-06-27
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2025-06-27
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-06-27
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-02-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-12-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-04-26
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-07-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2025-06-27
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-02-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-02-21
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2021-07-02
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2021-07-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-12-22
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-12-22
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2021-07-02
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2026-03-22
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2025-02-21
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	Class 2	882.5890	2025-02-21
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2020-12-21
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2020-12-21

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (571) 4072862

Related Public Records

Same Entity

Shenzhen Huayan E-commerce 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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
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

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 3017953405. Last updated year: 2026. Please use registration number 3017953405 when referencing this establishment in official correspondence.