FDA Registration
Active
🇩🇪 Germany
AKTORmed GmbH
Reg #: 3011390076
·
FEI: 3011390076
·
Expires 2026
Products
5
Proprietary Names
10
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- AKTORmed GmbH
- Registration Number
- 3011390076
- FEI Number
- 3011390076
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Neugablonzer Strasse 13
- City
- Neutraubling Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K233312
Owner / Operator
- Firm Name
- AKTORmed GmbH
- Operator Number
- 10059606
- Address
- Neugablonzer Strasse 13
- City
- Neutraubling
- State
- Bavaria
- Postal Code
- 93073
- Country
- DE
- Correspondent
- Robert Geiger
US Agent
- Business Name
- Micro Epsilon America
- Contact Name
- Martin Dumberger
- Address
- 8120 Browneigh Road
- City
- Raleigh
- State
- NC
- ZIP
- 27617
- Country
- US
- [email protected]
- Phone
- 919 7879707
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Software Controlled Endoscope And Instrument Holder | QZB | Class 2 | Gastroenterology, Urology | No | 2024-09-17 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2019-02-04 |
| Endoscope Holder | OCV | Class 2 | Gastroenterology, Urology | No | 2025-02-11 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2025-09-16 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2022-05-06 |
Proprietary Names
SOLOASSIST IID
Dexter Endoscope Arm
SOLOASSIST II
ARTip solo
SoloAsisst II, Voice Control
Robofix
Endofix EXO
Sterile Cover for SOLOASSIST II / Endofix EXO
Sterile Cover for Dexter Endoscope Arm
AKTORmed Probe Cover 30cm x 178cm
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device