Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029996046

FEI Number

3029996046

Entity Name

ZHENGZHOU LANGYI BIOTECH CO.,LTD

City/State/Country

Zhengzhou Henan, CN

Establishment Address

No.509, Floor 5, Building 4, No.27 fenglin road, Zhengzhou High-tech Industrial Development Zone, Zhengzhou Henan 450001, CN

Establishment Type(s)

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

Owner / Operator

Zhengzhou Langyi Biotech CO.,LTD (Owner Number: 10088906)

Owner / Operator Contact Address

No.509, Floor 5, Building 4, No.27 fenglin road, Zhengzhou High-tech Industrial Development Zone, Zhengzhou, CN-HA 450001, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Hydrogel Eye Patch, Disposable Hydrogel Patch; Pain Relief Gel Patch, Hydrogel Patch; Scar Patch Cooling Patch, Warm Patch, Cooling Gel Eye Patch, Cooling Gel Nose Patch, Cooling Eye Patch, Cooling Nose Patch, Cooling Gel patch, Fever Cooling Patch Anti Smoke Patch (Quit Smoking Patch), Diabetic patch, Nicotine Patch, Diarrhea Patch, Hypertension Patch, Medical Hypoallergenic Breathable Tape, Kinesiology Tape, Health Patch, Menthol Patch (Menthol Plaster), Ginger Patch (Ginger Plaster), Motion Sickness Patch, Vitamin Patch, Knee Patch, Sleep Aid Patch, Capsicum Plaster, Mugwort Patch, Aromatic Patch, Essential Oil Patch, Menopause Relief Patch (HotFlash Patch) Sleep Patch, Acupoint Patch, Hangover Patch, Capsicum Patch, Cough Relief Patch, Constipation Patch, Slimming Patch, Pain Relief Cold Patch, Pain Relief Patch, Pain Relief Patch, Period Pain Heat Patch, Joint Heat Patch Heat patch, Hot Patch, Acupoint Pressure Stimulation Patch, Menstrual Cramp Relief Patch, Pain Relief Heat Patch, Far Inirared Physiotherapy Patch, Far Infrared Pain Relief Heat Patch, Far Infrared Patch; Breast Health Patch Kidney Patch, Mosquito Repellent Patch, Prostate Patch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2023-10-20
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2026-02-01
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2023-10-20

Official Correspondent

Li Jia

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Zhengzhou Langyi Biotech 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

Registration Number	Establishment Name	Location
3024689458	CPM Solutions	South Windsor, CT, US
3031595576	SUZHOU SMH CO., LTD.	Suzhou Jiangsu, CN
3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029996046. Last updated year: 2026. Please use registration number 3029996046 when referencing this establishment in official correspondence.