Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025428426

FEI Number

3025428426

Entity Name

MEDCODES HEALTHCARE (SHENZHEN) LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

401, Building A, No.6 of Xinmu Road, Xinmu Community, Pinghu, Shenzhen Guangdong 518111, CN

Establishment Type(s)

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

Owner / Operator

Medcodes Healthcare (Shenzhen) Limited (Owner Number: 10086499)

Owner / Operator Contact Address

401, Building A, No.6 of Xinmu Road, Xinmu Community, Pinghu, Shenzhen, CN-GD 518111, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BABY NASAL ASPIRATOR NASA009 Electric Nasal Aspirator NASA608 EMS Foot Massager MH-1019 Electric Ear Waxremoval Device 2415 Queenwill KK-11; Queenwill H01; Queenwill H01B Massager: YX-710 SILICON FACIAL CLEANSING BRUSH SK0308 Heating FACIAL CLEANSING BRUSH, XPRE430 Warming Massage Cleaning Silicon Facial Brush SK0310 Sonic Electric Toothbrush L1 Sonic electric toothbrush X-3 Electric Nasal Irrigator N5201, N5202, N5260, N8001, N5280 medcodes F3, H5601, N5262, N5290, H5602, M7901 Teeth Bleaching Light W1001, W3001, W4002, W4003 medcodes W10, medcodes W20, medcodes W30, medcodes W40 Teeth Whitening Strip WS301, WS401 W4009,W4019,W4011,W4018,W4010,W4017,W4015,W4016,W4260,W4280

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2025-04-02
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	Class 2	878.4780	2025-07-24
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-07-24
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter	Neurology	Class 2	882.5890	2025-07-24
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-04-02
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-07-08
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2025-04-25
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2025-04-02
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2022-11-14
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2022-11-14

Official Correspondent

Bink Li

US Agent Details

Jessie Yao Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Medcodes Healthcare (Shenzhen) Limited

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
K221200	Xbody Hungary Kft.	XBody Go USA, XBody Pro USA	2023-01-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2007	Haemonetics Corporation	2	SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025428426. Last updated year: 2026. Please use registration number 3025428426 when referencing this establishment in official correspondence.