FDA Registration
Active
🇩🇪 Germany
MAQUET GMBH
Reg #: 8010652
·
FEI: 1841
·
Expires 2026
Products
12
Proprietary Names
31
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- MAQUET GMBH
- Registration Number
- 8010652
- FEI Number
- 1841
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- KEHLER STRASSE 31
- City
- RASTATT Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K201927
Owner / Operator
- Firm Name
- MAQUET GMBH
- Operator Number
- 8010652
- Address
- KEHLER STRASSE 31, --
- City
- RASTATT
- State
- Baden-Wurttemberg
- Postal Code
- 76437
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilizer, Steam | FLE | Class 2 | General Hospital | No | 2021-03-10 |
| Table, Radiographic, Stationary Top | IXQ | Class 2 | Radiology | No | 2018-11-16 |
| Table, Surgical With Orthopedic Accessories, Ac-Powered | JEA | Class 1 | General, Plastic Surgery | No | 2016-10-18 |
| Holder, Head, Radiographic | IWY | Class 1 | Radiology | No | 2016-01-28 |
| Table, Radiologic | KXJ | Class 2 | Radiology | No | 2001-09-24 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2012-05-09 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2004-08-20 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2015-07-30 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2016-10-18 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2001-11-27 |
| Table, Operating-Room, Manual | FSE | Class 1 | General, Plastic Surgery | No | 2001-11-27 |
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 2010-05-18 |
Proprietary Names
GSS610N10, GSS610N14, GSS610N15 Steam Sterilizer
1180.12F0 Multimodality Transfer Table Top
1180.71C0 Transfer Board
ALPHASTAR; YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA
YUNO II
GSS610N21 Series Steam Sterilizer
Rigid Head Rest 1002.82A0
1180.52A0 Multimodality Headrest, Fixed
MAQUET MAGNUS carbon-fibre table top (1180.16XX; T285.7000)
YUNO Femur Hook
Transmobile TT, Transmobile TT-M
Gel pads
Accessories to YUNO; ALPHAMAXX; ALPHASTAR PRO; MAGNUS; ALPHAMAQUET; BETASTAR; ALPHACLASSIC; OTESUS; MEERA
TRIMANO Fortis
TRIMANO
OTESUS
ALPHACLASSIC
MEERA, MEERA ST, MEERA CL
BETASTAR
ALPHASTAR PRO
MAGNUS
YUNO
ALPHASTAR
ORTHOSTAR
MAQUET OPERATING TABLES
ALPHAMAXX
ALPHAMAQUET
CORIN
BETACLASSIC
Getinge GSS67N Steam Sterilizer
Accessory to MAQUET OR Tables, Product no. 1005.XX
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device