Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011390076

FEI Number

3011390076

Entity Name

AKTORmed GmbH

City/State/Country

Neutraubling Bavaria, DE

Establishment Address

Neugablonzer Strasse 13, Neutraubling Bavaria 93073, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

AKTORmed GmbH (Owner Number: 10059606)

Owner / Operator Contact Address

Neugablonzer Strasse 13, Neutraubling, DE-BY 93073, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SOLOASSIST IID Dexter Endoscope Arm SOLOASSIST II ARTip solo SOLOASSIST II 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QZB	Software Controlled Endoscope And Instrument Holder	Gastroenterology, Urology	Class 2	876.1500	2024-09-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2019-02-04
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-01-05
OCV	Endoscope Holder	Gastroenterology, Urology	Class 2	876.1500	2025-02-11
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2025-09-16
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2022-05-06

Official Correspondent

Robert Geiger

US Agent Details

Martin Dumberger Business: Micro Epsilon America Email: Martin.Dumberger@micro-epsilon.com Phone: (919) 7879707

Related Public Records

Same Entity

AKTORmed GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06
K910084	Biocor Medical, Inc.	SURGICAL DRAPE	1991-03-19

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3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011390076. Last updated year: 2026. Please use registration number 3011390076 when referencing this establishment in official correspondence.