Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615662

FEI Number

3007671324

Entity Name

LABORATOIRES URGO

City/State/Country

CHEVIGNY SAINT SAUVEUR Cote-d'Or, FR

Establishment Address

EXCELLENCE 2000, 2 AVENUE DE STRASBOURG, CHEVIGNY SAINT SAUVEUR Cote-d'Or 21800, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LABORATOIRES URGO (Owner Number: 9029420)

Owner / Operator Contact Address

42, RUE DE LONGVIC, --, CHENOVE, FR-NOTA 21300, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143017

PMA Number

N/A

All Registered Proprietary Names

Urgotul Absorb; Urgotul Absorb Border Silicone URGOCLEAN Rope Urgotul URGOCLEAN Pad UrgoClean URGO K2; URGO K2 Lite URGO K1 Urgotul Ag/Silver Urgocell Ag/Silver Urgoclean Ag

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	2005-03-31
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2001-08-26
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2013-04-30
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2013-09-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-12-05
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	1997-02-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-02-10

Official Correspondent

SOPHIE FORTIN

US Agent Details

Steven Dowdley Business: Urgo Medical North America, LLC Email: steven.dowdley@us.urgo.com Phone: (678) 4518062

Related Public Records

Same Entity

LABORATOIRES URGO

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

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

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3008656870	DALIAN ORIENTECH CO.,LTD	Dalian Liaoning, CN
1629057	WINFIELD LABORATORIES, INC.	Richardson, TX, US
3021695082	BEONE CO., LTD.	Gimpo Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615662. Last updated year: 2026. Please use registration number 9615662 when referencing this establishment in official correspondence.