FDA Registration
Active
🇩🇪 Germany
DMG DIGITAL ENTERPRISES SE
Reg #: 3012623144
·
FEI: 3012623144
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- DMG DIGITAL ENTERPRISES SE
- Registration Number
- 3012623144
- FEI Number
- 3012623144
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Elbgaustrasse 248
- City
- Hamburg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K210940
Owner / Operator
- Firm Name
- DMG Digital Enterprises SE
- Operator Number
- 10079030
- Address
- Elbgaustrasse 248
- City
- Hamburg
- State
- DE-HH
- Postal Code
- 22547
- Country
- DE
- Correspondent
- Sinem Elif Bozkaya
US Agent
- Business Name
- Delphi Medical Device Consulting, Inc.
- Contact Name
- Pamela Papineau
- Address
- 5 WHITCOMB AVENUE
- City
- Ayer
- State
- MA
- ZIP
- 01432
- Country
- US
- [email protected]
- Phone
- 978 7588322
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2020-11-16 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2020-11-16 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2021-03-10 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2020-11-16 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2020-11-16 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2021-09-07 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2021-09-07 |
Establishment Types
Manufacture Medical Device