FDA Registration
Active
🇺🇸 United States
TYTEX, INC.
Reg #: 1225157
·
FEI: 3000206450
·
Expires 2026
Products
7
Proprietary Names
13
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- TYTEX, INC.
- Registration Number
- 1225157
- FEI Number
- 3000206450
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 24 Corliss Street, Unit 40458
- City
- Providence
- State
- RI
- ZIP
- 02940
- Country
- US
Owner / Operator
- Firm Name
- TYTEX Slovakia SRO
- Operator Number
- 9089779
- Address
- Chemlonska 1
- City
- Humenne
- State
- Presovsky
- Postal Code
- 06601
- Country
- SK
- Correspondent
- Ina Nemes
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Binder, Breast | HEF | Class 1 | General Hospital | No | 2006-07-14 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2006-07-14 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2006-07-17 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2006-07-14 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2018-07-11 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2006-07-14 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2006-07-14 |
Proprietary Names
BINDER
BREAST
CAREFIX-TUBE
HEAD
FINGER
TOE
GARMENT
FOR INCONTINENCE
LEGGYFIX
CAREFIX-CAREBAG
Brava
SAFEHIP
STOMASAFE
Establishment Types
Complaint File Establishment per 21 CFR 820.198