Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010690

FEI Number

2926

Entity Name

PAUL HARTMANN AG

City/State/Country

Heidenheim An Der Brenz Baden-Wurttemberg, DE

Establishment Address

Paul-Hartmann-Str. 12, Heidenheim An Der Brenz Baden-Wurttemberg 89522, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

PAUL HARTMANN AG (Owner Number: 8010690)

Owner / Operator Contact Address

481 Lakeshore Parkway, --, 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

Vintens Patient App Dignity Super Multiple Styles Moliform Multiple Styles Dignity, Multiple Styles Dignity Complete Multiple Styles Dignity Extra Multiple Styles Molimed Multiple Styles Dignity Compose Multiple Styles Molicare Multiple Styles Cosmopor Transparent Steril Hydrofilm HydroTac PERMAFOAM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2025-07-17
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-06-25
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2007-04-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2006-11-15
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2005-07-27
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2006-11-15
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2006-11-15

Official Correspondent

Lee Xiong

US Agent Details

Diane Marsilio Business: HARTMANN USA Email: diane.marsilio@hartmann.info Phone: (803) 9851120

Related Public Records

Same Entity

PAUL HARTMANN AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004623655	PAUL HARTMANN AG	BRUCK Brandenburg, DE
8031008	IVF HARTMANN AG	Neuhausen am Rheinfall Schaffhausen, CH
3029971427	PAUL HARTMANN Manufacturing Sp. z o.o.	Libidza Dolnoslaskie, PL
3003096716	Paul Hartmann Iberia S.A.	Montornes del Valles Barcelona, ES
3003111059	PAUL HARTMANN SAS	LIEPVRE Haut-Rhin, FR

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010690. Last updated year: 2026. Please use registration number 8010690 when referencing this establishment in official correspondence.