FDA Registration Active 🇩🇪 Germany

BAYER PHARMA, AG

Reg #: 3002808086 · FEI: 3002808086 · Expires 2026
Products
3
Proprietary Names
0
Establishment Types
2
Classifications
3

Registration Details

Registration Name
BAYER PHARMA, AG
Registration Number
3002808086
FEI Number
3002808086
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Mullerstrasse 178
City
Berlin
Country
DE

Regulatory Submissions

510(k) Number
K042784
PMA Number
P020014

Owner / Operator

Firm Name
Bayer Pharma, AG
Operator Number
10045903
Address
800 Dwight Way
City
Berkeley
State
CA
Postal Code
94710
Country
US

US Agent

Business Name
US RA CMC and Business Management
Contact Name
Mike Koenig
Address
100 Bayer Blvd
City
Whippany
State
NJ
ZIP
07981
Country
US
Phone
973 2879088

Products

Device Name Product Code
Introducer, Syringe Needle KZH
Transcervical Contraceptive Tubal Occlusion Device HHS
Injector And Syringe, Angiographic DXT

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device