Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027305775

FEI Number

3027305775

Entity Name

SURGEBRIGHT GMBH

City/State/Country

Lichtenberg Oberosterreich, AT

Establishment Address

Gewerbezeile 7, Lichtenberg Oberosterreich 4040, AT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

surgebright GmbH (Owner Number: 10087916)

Owner / Operator Contact Address

Gewerbezeile 7, Lichtenberg, AT-4 4040, AT

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
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-04-17
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-04-30
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2023-04-30

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

surgebright GmbH

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

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.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

Similar Registrations

Registration Number	Establishment Name	Location
3008816725	STRAUSS SURGICAL USA LLC.	Doral, FL, US
3039359037	BENTENG SCIENCE & TECHNOLOGY MEXICO SA DE CV	Pesqueria Nuevo Leon, MX
3008886285	Flextronics International Kft	Budapest, HU
3012574325	HAKAMA AG	Baettwil Solothurn, CH
3001397320	ROECHLING MEDICAL ROCHESTER L.P.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027305775. Last updated year: 2026. Please use registration number 3027305775 when referencing this establishment in official correspondence.