Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016654890

FEI Number

3016654890

Entity Name

ZHEJIANG LANHINE MEDICAL PRODUCTS LTD.

City/State/Country

Cixi City Zhejiang, CN

Establishment Address

No.99, 2nd Songpu Road, Binhai Economic Development Zone, Cixi City Zhejiang 315300, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Zhejiang Lanhine Medical Products Ltd. (Owner Number: 10063119)

Owner / Operator Contact Address

No.99, 2nd Songpu Road, Binhai Economic Development Zone, Cixi City, CN-ZJ 315300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FLUID RESISTANT SURGICAL MASK ; FLUID RESISTANT PROCEDURE MASK 3 poly face mask, surgical mask, face mask, Type IIR mask, ASTM II mask Face Shield Disposible Face Mask, ASTM I MASK, ASTM III Mask LEVEL 3 FLUID RESISTANT SURGICAL MASK ;LEVEL 3 FLUID RESISTANT PROCEDURE MASK Gel, Fever Reducing Gel, Cooling Gel, Antipyretic Gel Eye Shield Protective glasses KN95, FFP2, FFP3, N95, KF94, Children Mask, Children Hygiene Mask,Children Protective Mask Cotton Swab

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-09-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-30
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-11-24
IEX	Gelatin	Pathology	Class 1	864.4010	2024-07-09
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-07-21
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-24
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-07-09

Official Correspondent

Lianhe ZHONG

US Agent Details

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

Related Public Records

Same Entity

Zhejiang Lanhine Medical Products 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

Similar Registrations

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3016765490	XIAMEN CHUANFUTANG PHARMACEUTICAL CO.,LTD	xiamen Fujian, CN
3018382937	MID-AMERICA SAFETY CORP	Elk Grove Village, IL, US
3017598017	DURIO PPE SDN. BHD.	Johor Bahru, MY
3002813051	IRIS USA INC	Pleasant Prairie, WI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016654890. Last updated year: 2026. Please use registration number 3016654890 when referencing this establishment in official correspondence.