Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1218946

FEI Number

1218946

Entity Name

HARTMANN USA INC.

City/State/Country

ROCK HILL, SC, US

Establishment Address

481 LAKESHORE PKWY., ROCK HILL, SC 29730, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

HARTMANN USA, INC. (Owner Number: 10028346)

Owner / Operator Contact Address

481 Lakeshore PKWY, Rock Hill, SC 29730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pro's Choice Adhesive AC Tape Dignity Various styles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2010-11-04
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2017-08-30
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2009-02-05

Official Correspondent

Lee Xiong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HARTMANN USA, INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218946. Last updated year: 2026. Please use registration number 1218946 when referencing this establishment in official correspondence.