Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1950226

FEI Number

1950226

Entity Name

SIMMLER, INC.

City/State/Country

Saint Louis, MO, US

Establishment Address

2115 59th Street, Saint Louis, MO 63110, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIMMLER, INC. (Owner Number: 1950226)

Owner / Operator Contact Address

2115 59th Street, --, Saint Louis, MO 63110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fetal Cell Stain Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GHQ	Stain, Fetal Hemoglobin	Hematology	Class 2	864.7455	2007-12-06

Official Correspondent

Steven Caputa

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIMMLER, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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1000138378	SIGMA-ALDRICH CORP.	Saint Louis, MO, US
1938095	SURE-TECH DIAGNOSTIC ASSOCIATES, INC.	Saint Louis, MO, US
1938173	SIGMA-ALDRICH MANUFACTURING, LLC	ST. LOUIS, MO, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1950226. Last updated year: 2026. Please use registration number 1950226 when referencing this establishment in official correspondence.