FDA Registration
Active
🇫🇷 France
MAQUET S.A.S.
Reg #: 9710055
·
FEI: 3002465150
·
Expires 2026
Products
8
Proprietary Names
18
Establishment Types
2
Classifications
8
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Registration Details
- Registration Name
- MAQUET S.A.S.
- Registration Number
- 9710055
- FEI Number
- 3002465150
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PARC DE LIMERE, AVENUE DE LA POMME DE PIN
- City
- ARDON, ORLEANS CEDEX 2 Loiret
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K070442
Owner / Operator
- Firm Name
- MAQUET SAS
- Operator Number
- 9059038
- Address
- PARC DE LIMERE, AVENUE DE LA POMME DE PIN
- City
- Ardon
- State
- FR-NOTA
- Postal Code
- 45074
- Country
- FR
US Agent
- Business Name
- Maquet Cardiovascular LLC
- Contact Name
- Emily VALERIO
- Address
- 45 Barbour Pond Dr
- City
- Wayne
- State
- NJ
- ZIP
- 07470
- Country
- US
- [email protected]
- Phone
- 862 2215193
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Holder, Camera, Surgical | FXR | Class 1 | General, Plastic Surgery | No | 2009-11-09 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2018-11-20 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2008-03-05 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2019-01-02 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2009-12-15 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2022-03-14 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2002-07-10 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2008-11-14 |
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)
Maquet Orchide
VOLISTA ACCESS II
VOLISTA STANDOP II
VOLISTA
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)