Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011558129

FEI Number

3011558129

Entity Name

Avantor Performance Materials Poland S.A.

City/State/Country

Gliwice Slaskie, PL

Establishment Address

Ul. Sowinskiego 11, Gliwice Slaskie 44-101, PL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AVANTOR PERFORMANCE MATERIALS, LLC (Owner Number: 9003640)

Owner / Operator Contact Address

100 Matsonford Road, Suite 200, Radnor, PA 19087, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CELL-DYN Emerald 22 EASY CLEANER ALINITY H-SERIES MAY-GRUNWALD-GIEMSA STAIN ALINITY H-SERIES WRIGHT GIEMSA STAIN FACS SHUTDOWN SOLUTION FACS CLEAN FACS SHEATH SOLUTION FACSFLOW FIXATIVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCB	Detergent	Pathology	Class 1	864.4010	2015-12-21
GJL	Romanowsky Stains	Hematology	Class 1	864.1850	2023-10-12
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2007-08-29
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2007-08-29

Official Correspondent

Aubrey Buenger

US Agent Details

Aubrey Buenger Business: AVANTOR PERFORMANCE MATERIALS, LLC Email: Aubrey.Buenger@avantorsciences.com Phone: (805) 6730899

Related Public Records

Same Entity

AVANTOR PERFORMANCE MATERIALS, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1045125	AVANTOR PERFORMANCE MATERIALS, LLC	Paris, KY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K761138	Zeus Scientific, Inc.	FA TISSUE FIXATIVE & WASH SET	1978-01-06
K842913	E K Ind., Inc.	WRIGHT STAIN FIXATIVE	1984-09-07

Similar Registrations

Registration Number	Establishment Name	Location
3007268782	MicroCare CT - John Downey	New Britain, CT, US
1000206206	TECHNOGENETICS SPA	LODI, IT
3003453957	TECHNOCLONE	Vienna Wien, AT
3016438761	ABBOTT LABORATORIES	Irving, TX, US
3002809144	ABBOTT GmbH	Wiesbaden Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011558129. Last updated year: 2026. Please use registration number 3011558129 when referencing this establishment in official correspondence.