Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003027964

FEI Number

3003027964

Entity Name

Flex Precision Plastics Solutions (Switzerland) AG

City/State/Country

Hagglingen Aargau, CH

Establishment Address

Sonnhalde-Areal 5, Hagglingen Aargau 5607, CH

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

11706799001 Assay Tip Elecsys, 11706802001 Assay Cup Elecsys, 05694302001 AssayTip/AssayCup tray (E2G) 06241620001, MagNA Pure Tip 1000?L 03755525001, SPU 05534941001, Cobas Omni Amplification Plate, 12102137001, Assay Tip/Cup Elecsys Modular, 03137082001, Tube-K Box of 12x9 08863504001, Assay Tip tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2015-10-20

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
3008886285	Flextronics International Kft	Budapest, HU
3006126537	FLEXTRONICS INTERNATIONAL GMBH	ALTHOFEN Karnten, AT
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

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3008937875	Nissha FIS, Inc.	Osaka, JP
3004488394	TIGER MEDICAL GROUP	SHANGHAI, CN
3003542872	NPA de México S. de R.L. de C.V.	TIJUANA Baja California, MX
3011440888	PAYER International Technologies GMBH	St. Bartholomae Steiermark, AT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003027964. Last updated year: 2026. Please use registration number 3003027964 when referencing this establishment in official correspondence.