Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011334555

FEI Number

3011334555

Entity Name

Bayer Medical SRL

City/State/Country

Barreal de Heredia, CR

Establishment Address

Block B Lot 1, Metro Park, Barreal de Heredia 6-3060, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Bayer Medical Care Inc. (Owner Number: 2520313)

Owner / Operator Contact Address

1 Bayer Drive, Indianola, PA 15051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDRAD Dual Check Valve Transfer Set MEDRAD MR Transfer Set MEDRAD® Spectris Solaris EP MR Injection System MEDRAD® Disposable MRI Kit for 65/115 MR Injector System MEDRAD® Saline Syringe & Tubing for MR Injector System MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQH	Iodinated Contrast Media Transfer Tubing Set	General Hospital	Class 2	880.5440	2022-05-27
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2007-12-06

Official Correspondent

Troy Jack

US Agent Details

Troy Jack Business: Bayer Medical Care, Inc. Email: troy.jack@bayer.com Phone: (412) 3528280

Related Public Records

Same Entity

Bayer Medical Care 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
3006791331	Bayer Medical Care Inc.	Saxonburg, PA, US
3004056159	Bayer Medical Care Inc.	Pittsburgh, PA, US
2520313	Bayer Medical Care Inc.	INDIANOLA, PA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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2520313	Bayer Medical Care Inc.	INDIANOLA, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011334555. Last updated year: 2026. Please use registration number 3011334555 when referencing this establishment in official correspondence.