Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710055

FEI Number

3002465150

Entity Name

MAQUET S.A.S.

City/State/Country

ARDON, ORLEANS CEDEX 2 Loiret, FR

Establishment Address

PARC DE LIMERE, AVENUE DE LA POMME DE PIN, ARDON, ORLEANS CEDEX 2 Loiret 45074, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MAQUET SAS (Owner Number: 9059038)

Owner / Operator Contact Address

PARC DE LIMERE, AVENUE DE LA POMME DE PIN, Ardon, FR-NOTA 45074, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MAQUET EQUIPMENT Maquet Rolite XL Series Maquet Rolite Maquet Rolite M Series POWERLED PowerLED 300 Maquet PowerLED II Maquet EZEA LUCEA 10 LUCEA 40 LUCEA LED LUCEA 50 MAQUET STERIGRIP Medical Ceiling Supply Units; Model: MODUEVO (including MODUEVO-MA, ENERGY and PLG II)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2009-11-09
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2018-11-20
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2008-03-05
FTD	Lamp, Surgical	General, Plastic Surgery	Class 2	878.4580	2019-01-02
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2009-12-15
FTA	Light, Surgical, Accessories	General, Plastic Surgery	Class 2	878.4580	2022-03-14
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2002-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

Emily VALERIO Business: Maquet Cardiovascular LLC Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

MAQUET SAS

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
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Similar Registrations

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3012345110	Novadaq Technologies ULC	Burnaby British Columbia, CA
3015425104	Axcess Surgical Innovations, LLC	Houston, TX, US
3011092264	FLUOPTICS SAS	GRENOBLE Auvergne-Rhone-Alpes, FR
2916714	AESCULAP, INC.	CENTER VALLEY, PA, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710055. Last updated year: 2026. Please use registration number 9710055 when referencing this establishment in official correspondence.