Lumitex Medical Devices, Inc.

FDA Device Registration & Listing · Brecksville, OH, US · Registration 1000122810

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
1000122810
FEI Number
1000122810
Entity Name
Lumitex Medical Devices, Inc.
City/State/Country
Brecksville, OH, US
Establishment Address
6611 W Snowville Rd, Brecksville, OH 44141, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Lumitex Medical Devices, Inc. (Owner Number: 9000093)
Owner / Operator Contact Address
6611 W Snowville Rd, --, Brecksville, OH 44141, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K053568
PMA Number
N/A

All Registered Proprietary Names

Bilisoft 2 Phototherapy System, English Large Pad Bilisoft 2 Phototherapy System, Large Pad Bilisoft 2 Phototherapy System, Small Pad Bilisoft 2 Phototherapy System, English Small Pad Bilisoft Phototherapy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2017-06-22
LBI Unit, Neonatal Phototherapy General Hospital Class 2 880.5700 2009-05-07

Official Correspondent

Kimberly Tetuan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lumitex Medical Devices, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3030101746 Lumitex, Celaya Celaya Guanajuato, MX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000122810. Last updated year: 2026. Please use registration number 1000122810 when referencing this establishment in official correspondence.
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