Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3029971427

FEI Number

3029971427

Entity Name

PAUL HARTMANN Manufacturing Sp. z o.o.

City/State/Country

Libidza Dolnoslaskie, PL

Establishment Address

Wspolna 3, Libidza Dolnoslaskie 42-125, PL

Establishment Type(s)

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

Hydrofilm HydroTac PERMAFOAM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2006-11-15

Official Correspondent

Lee Xiong

US Agent Details

Diane Marsilio Business: PAUL HARTMANN AG Email: diane.marsilio@hartmann.info Phone: (803) 3492623

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
3003096716	Paul Hartmann Iberia S.A.	Montornes del Valles Barcelona, ES
3003111059	PAUL HARTMANN SAS	LIEPVRE Haut-Rhin, FR
3002521238	PAUL HARTMANN AG	HERBRECHTINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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 3029971427. Last updated year: 2026. Please use registration number 3029971427 when referencing this establishment in official correspondence.