FDA Registration
Active
🇺🇸 United States
HARTMANN USA INC.
Reg #: 1218946
·
FEI: 1218946
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- HARTMANN USA INC.
- Registration Number
- 1218946
- FEI Number
- 1218946
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 481 LAKESHORE PKWY.
- City
- ROCK HILL
- State
- SC
- ZIP
- 29730
- Country
- US
Owner / Operator
- Firm Name
- HARTMANN USA, INC.
- Operator Number
- 10028346
- Address
- 481 Lakeshore PKWY
- City
- Rock Hill
- State
- SC
- Postal Code
- 29730
- Country
- US
- Correspondent
- Lee Xiong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2010-11-04 |
| Stocking, Elastic | ILG | Class 1 | Physical Medicine | No | 2017-08-30 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2009-02-05 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2011-06-23 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2010-11-04 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2010-11-04 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2010-11-04 |
Proprietary Names
Pro's Choice Adhesive
AC Tape
Dignity Various styles
Disposable Bedding
REB
Shur-Band
AlumaFoam Splints
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198