Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013718153

FEI Number

3013718153

Entity Name

TALEXMEDICAL, LLC

City/State/Country

Malvern, PA, US

Establishment Address

5 Great Valley Parkway, Malvern, PA 19355, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TalexMedical,LLC (Owner Number: 10055353)

Owner / Operator Contact Address

5 Great Valley Parkway, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

InfantEar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2017-07-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TalexMedical,LLC

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 3013718153. Last updated year: 2026. Please use registration number 3013718153 when referencing this establishment in official correspondence.