BAYER PHARMA, AG

FDA Device Registration & Listing · Berlin, DE · Registration 3002808086

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002808086
FEI Number
3002808086
Entity Name
BAYER PHARMA, AG
City/State/Country
Berlin, DE
Establishment Address
Mullerstrasse 178, Berlin D-13353, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Bayer Pharma, AG (Owner Number: 10045903)
Owner / Operator Contact Address
800 Dwight Way, Berkeley, CA 94710, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K042784
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
KZH Introducer, Syringe Needle General Hospital Class 2 880.6920 2016-08-11
HHS Transcervical Contraceptive Tubal Occlusion Device Obstetrics/Gynecology Class 3 884.5380 2014-01-10
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2017-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

Mike Koenig Business: US RA CMC and Business Management Email: mike.koenig@bayer.com Phone: (973) 2879088

Related Public Records

Same Entity

Bayer Pharma, AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2243252 Bayer HealthCare, LLC Morristown, NJ, 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002808086. Last updated year: 2026. Please use registration number 3002808086 when referencing this establishment in official correspondence.
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