Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030172764

FEI Number

3030172764

Entity Name

DEUFOL WAREMME OPERATIONS

City/State/Country

Waremme Liege, BE

Establishment Address

Rue du Parc Industriel 29, Waremme Liege 4300, BE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Deufol Waremme Operations (Owner Number: 10089314)

Owner / Operator Contact Address

Rue du Parc Industriel 29, Waremme, BE-WLG 4300, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123892

PMA Number

N/A

All Registered Proprietary Names

Z-Flo Fluidized Positioner Biogel PI Mepore Film Mepitel One Mepitel Mepitel Film Exufiber Ag+ Barrier Medical Face Mask Mepilex Border Melgisorb Plus, Cavity Mepore Film & Pad Mepilex Lite Mepilex Border Flex Lite Mepilex XT Mepilex Melgisorb Plus Lyofoam Max Mesalt Mepore Mepilex Border Flex Mepore Pro Mepilex Up Mepilex Border Lite Mepilex Border Sacrum Mestopore Mepilex Heel Mepilex Border Post-Op Exufiber Mextra Superabsorbent Mepilex Transfer Alldress Mepilex Border Heel Mepore Film and Pad Mepitac Mefix Mepiform Barrier Nurse's Cap Headcovering Barrier Surgical Hood Barrier Surgical Cap Elset Setopress Tubigrip Tubifast Mepilex Transfer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2024-12-03
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-12-18
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2023-12-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-18
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-11-25
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2023-12-18
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-12-18
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-12-18
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2023-12-18
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-12-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-18

Official Correspondent

Ronald Schrooten

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@Registrarcorp.Com Phone: (757) 2240177

Related Public Records

Same Entity

Deufol Waremme Operations

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24

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.

Similar Registrations

Registration Number	Establishment Name	Location
3004632523	Eduard Gerlach Gmbh	Luebbecke North Rhine-Westphalia, DE
3038624835	DONGGUAN HEECOOL TECHNOLOGY CO., LTD.	Dongguan Guangdong, CN
3010364377	Flexor SA	Barbera del Valles Barcelona, ES
3016232365	SHENZHEN FOAMTECH CO., LTD	Shenzhen Guangdong, CN
2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030172764. Last updated year: 2026. Please use registration number 3030172764 when referencing this establishment in official correspondence.