Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006379619

FEI Number

3006379619

Entity Name

Lohmann & Rauscher GmbH

City/State/Country

Schoenau an der Triesting Niederosterreich, AT

Establishment Address

Kirchengasse 17, Schoenau an der Triesting Niederosterreich 2525, AT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

LOHMANN & RAUSCHER GMBH & CO. KG (Owner Number: 8010825)

Owner / Operator Contact Address

WESTERWALDSTRASSE 4, --, RENGSDORF, DE-NOTA 56579, DE

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
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2000-01-14
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2016-03-23

Official Correspondent

No official correspondent registered.

US Agent Details

Sam Shaffer Business: L&R USA INC. Email: sam.shaffer@us.LRmed.com Phone: (414) 8924157

Related Public Records

Same Entity

LOHMANN & RAUSCHER GMBH & CO. KG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009589349	Lohmann & Rauscher s.r.o.	Nová Paka Jicin, CZ
3016119195	Lohmann & Rauscher Hubei Medical Products Co., Ltd.	Xishui County Hubei, CN
3010804499	Lohmann & Rauscher s.r.o.	Stara Paka Jicin, CZ
3011816517	Lohmann & Rauscher s.r.o	Slavkov u Brna Jihomoravsky Kraj, CZ
3002468342	LOHMANN & RAUSCHER GMBH & CO. KG	NEUWIED Rhineland-Palatinate, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

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3012677665	TECHNO PLASTICS INDUSTRIES, INC.	Anasco, PR, US
3038131023	UNITED TECHNOLOGY VIETNAM COMPANY LIMITED	Quang Ha Commune Quang Ninh, VN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3043106338	SHENZHEN SPONGE NEW MATERIAL CO. LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006379619. Last updated year: 2026. Please use registration number 3006379619 when referencing this establishment in official correspondence.