FDA Registration
Active
🇺🇸 United States
COPAL® exchange G
Reg #: 3013186738
·
FEI: 3013186738
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Heraeus Medical LLC
- Registration Number
- 3013186738
- FEI Number
- 3013186738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- Township Line Road 770, Suite 300
- City
- Yardley
- State
- PA
- ZIP
- 19067
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191016
Owner / Operator
- Firm Name
- Heraeus Medical GmbH
- Operator Number
- 10048423
- Address
- Philipp-Reis-Str. 8/13
- City
- Wehrheim
- State
- Hesse
- Postal Code
- 61273
- Country
- DE
- Correspondent
- Benjamin Hagedorn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2019-11-22 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2019-11-22 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-11-22 |
Proprietary Names
COPAL® exchange G
Establishment Types
Complaint File Establishment per 21 CFR 820.198