Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033334123

FEI Number

3033334123

Entity Name

FACTOR MEDICAL, INC

City/State/Country

Newtown, PA, US

Establishment Address

41 University Dr Ste 400, Newtown, PA 18940, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Factor Medical, Inc (Owner Number: 10051553)

Owner / Operator Contact Address

41 University Drive, Ste 400, Newtown, PA 18940, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SELPHYLLER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2024-11-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Factor Medical, 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
3012453008	FACTOR MEDICAL Inc.	Concord, MA, US

Similar Registrations

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3033848228	JOAN LAB EQUIPMENT (ZHEJIANG) CO.,LTD.	Huzhou Zhejiang, CN
3008514604	SCIGENE	Santa Clara, CA, US
3005174594	NANO-DITECH CORPORATION	Cranbury, NJ, US
1319130	Crosstex International	Rush, NY, US
8043629	SCICAN LTD.	TORONTO Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033334123. Last updated year: 2026. Please use registration number 3033334123 when referencing this establishment in official correspondence.