Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030927217

FEI Number

3030927217

Entity Name

SOMATEX Medical Technologies GmbH

City/State/Country

Berlin, DE

Establishment Address

Kaiserin-Augusta-Allee 112/113, Berlin 10553, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HOLOGIC, INC. (Owner Number: 9007676)

Owner / Operator Contact Address

250 Campus Drive, --, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tumark Q Tumark Professional Tumark Vision Tumark Professional Q-Shape Tumark Professional Tumark for Brevera Tumark Vision Tumark for Eviva Tumark Professional Q TuLoc TuLoc Premium TuFlex Premium TuFlex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-12-10
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2017-03-24
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-12-10
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2017-03-24
MIJ	Needle, Tumor Localization	General, Plastic Surgery	Class 1	878.4800	2025-12-10

Official Correspondent

Sue Dahlquist

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

HOLOGIC, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013649990	HEALTH BEACONS, INC.	Marlborough, MA, US
3012644426	ENDOMAGNETICS LTD	Cambridge Cambridgeshire, GB
3005875675	GYNESONICS, INC.	REDWOOD CITY, CA, US
3006330030	Hologic, Inc.	Marlborough, MA, US
3010377594	BOLDER SURGICAL, LLC	LOUISVILLE, CO, US

Similar Registrations

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3013649990	HEALTH BEACONS, INC.	Marlborough, MA, US
3026851515	VDL TBP ELECTRONICS	Dirksland Zuid-Holland, NL
3015924373	AUSA Medical Device Pvt Ltd	Bangalore Karnataka, IN
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030927217. Last updated year: 2026. Please use registration number 3030927217 when referencing this establishment in official correspondence.