Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006113180

FEI Number

3006113180

Entity Name

AYGUN SURGICAL INSTRUMENTS CO.,INC.

City/State/Country

Kutlukent, Samsun, TR

Establishment Address

ORGANIZE SANAYI BOLGESI, Kutlukent, Samsun 55330, TR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AYGUN SURGICAL INSTRUMENTS CO.,INC. (Owner Number: 9089161)

Owner / Operator Contact Address

ORGANIZE SANAYI BOLGESI, Kutlukent, Samsun, TR-55 55330, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: Business Support International Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

AYGUN SURGICAL INSTRUMENTS CO.,INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11
K112536	Covidien	SONICISION STERILIZATION TRAY	2012-04-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006113180. Last updated year: 2026. Please use registration number 3006113180 when referencing this establishment in official correspondence.