Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8031008

FEI Number

3004704752

Entity Name

IVF HARTMANN AG

City/State/Country

Neuhausen am Rheinfall Schaffhausen, CH

Establishment Address

Victor-von-Bruns-Strasse 28, Neuhausen am Rheinfall Schaffhausen 8212, CH

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

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2007-12-11

Official Correspondent

Lee Xiong

US Agent Details

Diane Marsilio Business: PAUL HARTMANN AG 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
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
3002521238	PAUL HARTMANN AG	HERBRECHTINGEN Baden-Wurttemberg, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8031008. Last updated year: 2026. Please use registration number 8031008 when referencing this establishment in official correspondence.