Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006609021

FEI Number

3006609021

Entity Name

TYTEX DENMARK A/S

City/State/Country

IKAST Midtjylland, DK

Establishment Address

MARSVEJ 6, IKAST Midtjylland 7430, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

TYTEX Slovakia SRO (Owner Number: 9089779)

Owner / Operator Contact Address

Chemlonska 1, Humenne, SK-PV 06601, SK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAFEHIP Brava BINDER BREAST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2006-07-14
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2018-07-11
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2006-07-14

Official Correspondent

Ina Nemes

US Agent Details

Mauricio A. Morales Business: Tytex Inc. Email: mam@tytex.com Phone: (401) 7624100

Related Public Records

Same Entity

TYTEX Slovakia SRO

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006121457	TYTEX SLOVAKIA S.R.O.	HUMENNE Presovsky, SK
1225157	TYTEX, INC.	Providence, RI, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006609021. Last updated year: 2026. Please use registration number 3006609021 when referencing this establishment in official correspondence.