Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004980986

FEI Number

3004980986

Entity Name

JIANYI ENTERPRISES

City/State/Country

TIANMEN Hubei, CN

Establishment Address

NO.28. TIANXIAN AVENUE, TIANMEN INDUSTRIAL PARK,, TIANMEN Hubei 431700, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

JIANYI ENTERPRISES (Owner Number: 9083026)

Owner / Operator Contact Address

NO.28. TIANXIAN AVENUE, TIANMEN INDUSTRIAL PARK,, TIANMEN, CN-HB 431700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NONWOVEN BOOT COVERS NONWOVEN BRIEFS NONWOVEN SHORTS NONWOVEN SHOE COVERS NONWOVEN LAB COATS NONWOVEN COVERALLS PE SHOE COVERS PE GLOVES PE SLEEVE COVERS PE GOWNS NONWOVEN HOODS HAIRNETS BOUFFANT CAPS KORONETS BEARD COVERS NONWOVEN CAPS NONWOVEN SHOE COVERS, PE SHOE COVERS Civilian Face Masks Non-medical Face mask Nonwoven Gowns, Coveralls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2007-08-24
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2007-08-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2009-10-21
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-04-07
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2009-07-23

Official Correspondent

CHEN WEN

US Agent Details

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

Related Public Records

Same Entity

JIANYI ENTERPRISES

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004980986. Last updated year: 2026. Please use registration number 3004980986 when referencing this establishment in official correspondence.