Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017071994

FEI Number

3017071994

Entity Name

HEFEI BOX MEDICAL INNOVATION CO., LTD

City/State/Country

Hefei City Anhui, CN

Establishment Address

Floor 1, Building2, No.8, Jinrong Road, Shuangfeng Economic Development Zone, Hefei City Anhui 231131, CN

Establishment Type(s)

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

Owner / Operator

Hefei Box Medical Innovation Co., Ltd (Owner Number: 10071205)

Owner / Operator Contact Address

Floor 1, Building2, No.8, Jinrong Road, Shuangfeng Economic Development Zone, Hefei City, CN-AH 231131, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-20

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Hefei Box Medical Innovation 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 3017071994. Last updated year: 2026. Please use registration number 3017071994 when referencing this establishment in official correspondence.