BAYLAB USA

FDA Device Registration & Listing · Dallas, TX, US · Registration 3017517827

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017517827
FEI Number
3017517827
Entity Name
BAYLAB USA
City/State/Country
Dallas, TX, US
Establishment Address
2230 LBJ FREEWAY, Suite 100, Dallas, TX 75234, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
BayLab USA (Owner Number: 10078379)
Owner / Operator Contact Address
2230 LBJ FREEWAY, Suite 100, Dallas, TX 75234, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BAYLAB USA Surgical Mask BL3-59941 BLK-39425 BLW-64926 BL3-50221

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 2021-12-13
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 2020-10-20

Official Correspondent

Ashley Park

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BayLab USA
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017517827. Last updated year: 2026. Please use registration number 3017517827 when referencing this establishment in official correspondence.
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