Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611462

FEI Number

3002807486

Entity Name

LOHMANN & RAUSCHER GMBH & CO. KG

City/State/Country

NEUWIED Rhineland-Palatinate, DE

Establishment Address

IRLICHER STRASSE 55, NEUWIED Rhineland-Palatinate 56567, DE

Establishment Type(s)

Manufacture Medical Device

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
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2000-12-14
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2000-12-14
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2013-02-18
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2002-03-06
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2000-01-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2000-12-14
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2007-11-07
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2000-12-14

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
3006379619	Lohmann & Rauscher GmbH	Schoenau an der Triesting Niederosterreich, AT
3011816517	Lohmann & Rauscher s.r.o	Slavkov u Brna Jihomoravsky Kraj, CZ

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
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10

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 9611462. Last updated year: 2026. Please use registration number 9611462 when referencing this establishment in official correspondence.