FDA Registration
Active
🇺🇸 United States
Bayer HealthCare, LLC
Reg #: 2243252
·
FEI: 2243252
·
Expires 2026
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Bayer HealthCare, LLC
- Registration Number
- 2243252
- FEI Number
- 2243252
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 36 Columbia Rd
- City
- Morristown
- State
- NJ
- ZIP
- 07960
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2017-10-31 |
| Transcervical Contraceptive Tubal Occlusion Device | HHS | Class 3 | Obstetrics/Gynecology | No | 2014-01-10 |
| Introducer, Syringe Needle | KZH | Class 2 | General Hospital | No | 2016-08-11 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198