Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006126537

FEI Number

3006126537

Entity Name

FLEXTRONICS INTERNATIONAL GMBH

City/State/Country

ALTHOFEN Karnten, AT

Establishment Address

FRIESACHER STRASSE 3, ALTHOFEN Karnten A-9330, AT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Flextronics International USA, Inc. (Owner Number: 9006592)

Owner / Operator Contact Address

12455 Research Blvd, Austin, TX 78759, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AutoTouch reusable auto injector Tempo Smart Button

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZH	Introducer, Syringe Needle	General Hospital	Class 2	880.6920	2015-03-13
OCN	Insulin Autoantibody Kit	Immunology	Class 2	866.5660	2022-11-22
QOG	Injection Data Capture Device	General Hospital	Class 2	880.5860	2022-11-22

Official Correspondent

Chad Ashton

US Agent Details

Chad Ashton Business: FLEXTRONICS INTERNATIONAL USA, INC. Email: chad.ashton@flex.com Phone: (901) 8712423

Related Public Records

Same Entity

Flextronics International USA, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003027964	Flex Precision Plastics Solutions (Switzerland) AG	Hagglingen Aargau, CH
3008886285	Flextronics International Kft	Budapest, HU
3021010223	Flex Precision Plastics Solutions AG	Kussnacht Schwyz, CH
3022473387	Flextronics Medical Molding (Shenzhen) Co., Ltd	Shenzhen Guangdong, CN
3011536730	Flextronics International USA	Buffalo Grove, IL, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006126537. Last updated year: 2026. Please use registration number 3006126537 when referencing this establishment in official correspondence.