Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016218280

FEI Number

3016218280

Entity Name

ENDERS COLSMAN AG

City/State/Country

Werdohl North Rhine-Westphalia, DE

Establishment Address

Brauck 1, Iserlohn HRB 5661, Werdohl North Rhine-Westphalia 58791, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Enders Colsman AG (Owner Number: 10061926)

Owner / Operator Contact Address

Brauck 1, Werdohl, DE-NW 58791, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SteriSet Sterilization Container

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2019-12-03

Official Correspondent

Alexander Zuchowski

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Enders Colsman AG

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
2523664	M & Q PACKAGING LLC	SCHUYLKILL HAVEN, PA, US
9680031	STEPAC L.A., LTD.	TEFEN, WESTERN GALILEE Northern, IL
9616096	La Ada de Acuna	CIUDAD DE ACUNA Coahuila, MX
1054380	Halyard North Carolina, LLC	LINWOOD, NC, US
8030674	ESPECIALISTAS EN ESTERILIZACION Y ENVASE, S. A. DE C. V.	Tlalnepantla, Estado de Mexico, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016218280. Last updated year: 2026. Please use registration number 3016218280 when referencing this establishment in official correspondence.