Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012267116

FEI Number

3012267116

Entity Name

VARA HOME FASHION COMPANY LIMITED

City/State/Country

Hong Kong, CN

Establishment Address

Suite 101, 1/F, Kai Wong Commercial Building, 222 Queen Road Central, Hong Kong 00000, CN

Establishment Type(s)

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

Owner / Operator

Vara Home Fashion Shanghai Co., LTD (Owner Number: 10050118)

Owner / Operator Contact Address

425 YiShan Road, Suite 2306-2310, Guang Qi Cheng, CN-SH 200235, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-23
FME	Gown, Examination	General Hospital	Class 1	880.6265	2015-11-13
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2021-12-29
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2021-12-29
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2020-04-02
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2018-07-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-29

Official Correspondent

Sherry He

US Agent Details

Robin Quill Business: Vara Home USA Email: rquill@varahomeusa.com Phone: (704) 7524189

Related Public Records

Same Entity

Vara Home Fashion Shanghai Co., LTD

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 3012267116. Last updated year: 2026. Please use registration number 3012267116 when referencing this establishment in official correspondence.