FDA Registration
Active
🇩🇪 Germany
RCM
Reg #: 8043762
·
FEI: 3002807157
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HEIDELBERG ENGINEERING GMBH
- Registration Number
- 8043762
- FEI Number
- 3002807157
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Max-Jarecki-Str. 8
- City
- HEIDELBERG Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K042742
Owner / Operator
- Firm Name
- Heidelberg Engineering GmbH
- Operator Number
- 9003668
- Address
- Max-Jarecki-Str. 8
- City
- Heidelberg
- State
- Baden-Wurttemberg
- Postal Code
- 69115
- Country
- DE
- Correspondent
- Rene Betz
US Agent
- Business Name
- HEIDELBERG ENGINEERING, U.S. Corporate Office
- Contact Name
- Ricky Lopez
- Address
- 10 Forge PKWY
- City
- Franklin
- State
- MA
- ZIP
- 02038
- Country
- US
- [email protected]
- Phone
- 508 5317820
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2006-11-16 |
Proprietary Names
RCM
Rostock Cornea Module
TOMOCAP
Establishment Types
Manufacture Medical Device