Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006121457

FEI Number

3006121457

Entity Name

TYTEX SLOVAKIA S.R.O.

City/State/Country

HUMENNE Presovsky, SK

Establishment Address

Polna 15, HUMENNE Presovsky 066 01, SK

Establishment Type(s)

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

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

CAREFIX-TUBE HEAD FINGER TOE SAFEHIP BINDER BREAST GARMENT FOR INCONTINENCE LEGGYFIX CAREFIX-CAREBAG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-07-14
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2006-07-14
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2006-07-14
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2006-07-17
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-07-14

Official Correspondent

Ina Nemes

US Agent Details

Mauricio A. Morales 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
3006609021	TYTEX DENMARK A/S	IKAST Midtjylland, DK
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 3006121457. Last updated year: 2026. Please use registration number 3006121457 when referencing this establishment in official correspondence.