Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010393565

FEI Number

3010393565

Entity Name

RINGELE AG

City/State/Country

Pratteln Basel-Landschaft, CH

Establishment Address

Wasenstrasse 49, Pratteln Basel-Landschaft 4133, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ringele AG (Owner Number: 10044725)

Owner / Operator Contact Address

Wasenstrasse 49, Pratteln, CH-BL 4133, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Synthes Graphic Case & Tray System

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	2025-06-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2022-02-24

Official Correspondent

Sebastian Strahm

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Ringele AG

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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1526531	STERIS Corporation	CLEVELAND, OH, US
3005706667	TURNER MEDICAL INC.	Athens, AL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010393565. Last updated year: 2026. Please use registration number 3010393565 when referencing this establishment in official correspondence.