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
Phone
919 7879707

Products

Device Name Product Code
Software Controlled Endoscope And Instrument Holder QZB
System, Surgical, Computer Controlled Instrument NAY
Endoscope Holder OCV
Drape, Surgical, Antimicrobial KKX
Drape, Surgical, Exempt PUI

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