Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009591332

FEI Number

3009591332

Entity Name

THUASNE SAS

City/State/Country

SAINT ETIENNE Hauts-de-Seine, FR

Establishment Address

27 rue de la Jomayere, SAINT ETIENNE Hauts-de-Seine 42000, FR

Establishment Type(s)

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

Owner / Operator

Thuasne S.A.S. (Owner Number: 10094514)

Owner / Operator Contact Address

120 rue Marius Aufan, Levallois-Perret, FR-NOTA 92300, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SLEEQ Adapt 456 Osteomed Acute SLEEQ Max SLEEQ Flex Back Belt Dorso Rigid T35 Dorso Rigid Dorso Rigid 35 Sleeq Extension Panel SLEEQ + Flex BOA Duel TLSO Venoflex City Venoflex Kokoon Venoflex Fast Lin Venoflex Fast Coton Venoflex Fast Air Venoflex Secret Venoflex Fast Laine Venoflex Incognito Absolu Venoflex Elegance Venoflex Secret Opaque Venoflex Soft&Care Venoflex Fast Polyamide Venoflex Clinic Mobiderm Standard Mitten Mobiderm Standard Armsleeve Mobiderm Intimate- bra Mobiderm Made to measure Mobiderm Intimate Bra Mobiderm Mobilizing Pads Mobiderm Autofit Sock Mobiderm Autofit Armsleeves Mobiderm - Pad for short, woman version Mobiderm - Pad for short, man version Mobiderm Standard Glove Mobiderm Intimate shorts Lymphatrex Revolution Mobiderm Autofit Socking Protective liner - socks Short Stretch Cotton Bandage Thuasne-Compressive Gloves and toe cap Mobiderm Mobilizing Bandages MOBIDERM KIT BOA LP 8 SLEEQ APL Lombatech Pro SLEEQ AIR AP+ SLEEQ ADAPT 639 Reversa ProMaster Lombaskin Pro SLEEQ AP SLEEQ ADAPT BOA Slim Panel XTR Lombastab SLEEQ AIR APL Lombamum BOA w/Chairback SLEEQ AP+ Lombatech BOA SI SLEEQ AIR AP Biflex Self Adjust Biflex 16+ Biflex 17+ Biplast BiFlexideal Kit BiFlex Collar Ortel C2+ Collar C4 Eclipse Cervical Collar Collar Ortel C2 Plus Collar C4 Vario Collar Thuasne C1 Collar Ortel C1 Junior Eclipse EXT Cervical Collar Ortel C42 Vario Clavicular Ligaflex Clavicular Ligaflex Junior Arm sling Townsend Shoulder Sling AeroSling Shoulder Immobilization Vest Immo Classic TD Shoulder Sling Elite Shoulder Sling SpryStep Neuro Stat-A-Dyne Knee Rebel 3D Genu Pro Activ Stat-A-Dyne ESP Air Townsend Reliever One Dynamic KAFO Premier SPRYSTEP VECTOR KAFO Sports Series Select Reliever Active Reliever Stat-A-Dyne Wrist Stat-A-Dyne Ankle Genuextrem Premier Trigger ROMX SS Ligastrap Genu Reliever Argicalm Th Sport Patella Reliever Premier Reliever Air Townsend Reliever Compression Calf Sleeves Stat-A-Dyne WHFO RebelPro Rebel Reliever Premier KAFO Bold Full Shell BK Compression Socks Stat-A-Dyne Shoulder GenuStart Dynamic Reliever Reliever Air Lite Rebel Lock ROM-R Genu Ligaflex ROM 4 ExoGuard Action Reliever Stat-A-Dyne Elbow Motocross Series Silistab Genu SpryStep Ligament Reliever Air Full Shell KAFO TS ROM SpryStep OA Rebel The Crusader Genu ProMaster ROM-LX Genu Dynastab Genu Ligaflex ROM Stat-A-Dyne Pronation / Supination PR1 Softforce Reliever UniReliever GenuStart ROM Full Shell ROM 6 SpryStep Footplate SpryStep Carbon Footplate SpryStep Agilik KAFO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2025-12-04
ILG	Stocking, Elastic	Physical Medicine	Class 1	890.3475	2025-12-04
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2025-12-04
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2025-12-04
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2025-12-04
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2025-12-04
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2025-12-04
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2025-12-04
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2025-12-04
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Thuasne S.A.S.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8010658	THUASNE DEUTSCHLAND GMBH	Burgwedel Lower Saxony, DE
3011678115	Textile Medicale	Arad, RO
3012027699	Thuasne Czech Republic S.R.O	PREDKLASTERI Brno-Venkov, CZ

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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3012453117	TREND MEDICAL, LLC	Bethlehem, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009591332. Last updated year: 2026. Please use registration number 3009591332 when referencing this establishment in official correspondence.