Kinetec SAS
France FR-MF-000000364 Last updated 22 Oct 2026
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- Devices
- 32
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Pre-Cut Thermoplastic Sheet Ref M7FPLWN100WH
Pre-Cut Thermoplastic Sheet Ref M7THLWN100WH
Pre-Cut Thermoplastic Sheet Ref M7HTOWN300WH
Pre-Cut Thermoplastic Sheet Ref M7HOOWN300WH
Pre-Cut Thermoplastic Sheet Ref M7THSON100WH
Pre-Cut Thermoplastic Sheet Ref M7FPLCN100WH
Pre-Cut Thermoplastic Sheet Ref M7FPSWN100WH
Pre-Cut Thermoplastic Sheet Ref M7THSWN100WH
Pre-Cut Thermoplastic Sheet Ref M7THLON100WH
Pre-Cut Thermoplastic Sheet Ref M7HTOON300WH
Pre-Cut Thermoplastic Sheet Ref M7EOOCN100WH
Pre-Cut Thermoplastic Sheet Ref M7FPSCN100WH
Kinevia Al Ref Z12069099
Kinevia AL+ Ref 46210101EU
Prima Advance - KINETEC SAS Ref 46210080XX
Performa - Kinetec SAS Ref 46210018XX
Spectra Essential - KINETEC SAS Ref 46210062XX
Prima Extra - KINETEC SAS Ref 46210082XX
Kinetec SAS Ref 46210060X3
Kinetec CEM avec chaise Ref 462100380X
Kinevia Duo - KINETEC SAS Ref 462100900X
Kinetec SAS Ref 462100650X
Kinetec SAS Ref 462100500X
Kinetec CEM module de coude Ref 462100700X
Kinetec Spectra Kompanion - KINETEC SAS Ref 4621K060XX
Kinevia - KINETEC SAS Ref 03760246246996
Spectra XL - Kinetec SAS Ref 46210068XX
Centura Lite Ref 4621033X0X
Spectra - KINETEC SAS Ref 46210060XX
Optima Essential - KINETEC SAS Ref 46210062X3
Kinetec Optima Kompanion - KINETEC SAS Ref 4621K06003
Kinetec Centura B&W Ref 462100360X
EUDAMED certificates
GMED SAS 0459 1 certificate
- 40482 Supplemented
Quality management system EU MDR
- Issued
- 24 Aug 2026
- Expires
- 15 Apr 2031
- Reason
- Other
Related companies
Notified bodies
- GMED SAS 0459
What Kinetec SAS makes
Kinetec SAS manufactures medical devices primarily for patient positioning and support, including adjustable hospital beds (e.g., Prima Advance, Performa, Spectra Essential, Prima Extra, and the 6080 series with optional armrest and elbow modules), as well as mobility aids like the Kinevia and Centura Lite.
These devices are classified as Class IIa under EU regulations and are listed in the EUDAMED registry. The company is based in France.
Frequently asked questions
What types of medical devices does Kinetec SAS manufacture?
Kinetec SAS specializes in medical devices focused on patient positioning and support. Their product range includes adjustable hospital beds such as the Prima Advance, Performa, Spectra Essential, Prima Extra, and the 6080 series (with optional armrest and elbow modules). They also produce mobility aids like the Kinevia and Centura Lite, which assist patients in movement and transfer.
Where is Kinetec SAS based?
Kinetec SAS is headquartered in France. The company’s location in France aligns with its focus on manufacturing medical devices that comply with European regulatory standards.
Which regulatory registries list Kinetec SAS’s devices?
Kinetec SAS’s devices are listed in the EUDAMED registry, which is the official European database for medical devices. This registry tracks devices that have undergone the necessary conformity assessments under EU regulations.
How are Kinetec SAS’s devices classified under EU regulations?
Kinetec SAS’s devices fall under Class IIa classification in the EU. This classification is assigned based on the risk associated with the device—Class IIa devices pose a moderate risk and require additional scrutiny, such as clinical evaluations or performance studies, to ensure safety and performance before market placement.
Information
- Country
- France
- Address
- Z.I de Tournes - rue Maurice Périn, Tournes, France
- Website
- kinetec.fr
- [email protected]
- PRRC contact
- Jean-Nicolas PAGANO
- EUDAMED SRN
- FR-MF-000000364
- FDA FEI number
- 3006734242