Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225157

FEI Number

3000206450

Entity Name

TYTEX, INC.

City/State/Country

Providence, RI, US

Establishment Address

24 Corliss Street, Unit 40458, Providence, RI 02940, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEF	Binder, Breast	General Hospital	Class 1	880.5160	2006-07-14
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	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
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2018-07-11
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2006-07-14
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2006-07-14

Official Correspondent

Ina Nemes

US Agent Details

No US Agent registered (Local establishment).

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
3006121457	TYTEX SLOVAKIA S.R.O.	HUMENNE Presovsky, SK

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3013498096	Foshan Nanhai Jianli Underwear Co., LTD	Foshan City Guangdong, CN
3014457829	DALIAN SPORTECH APPAREL CO., LTD	Dalian Liaoning, CN
3008114969	Zhejiang Rehan Medical Manufacturing Co., Ltd.	Jiaxing City Zhejiang, CN
1525724	GOLDA, INC.	BEACHWOOD, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225157. Last updated year: 2026. Please use registration number 1225157 when referencing this establishment in official correspondence.