Synergie Nederland
Active in EUDAMEDNetherlandsfrom SRN EUDAMED SRN NL-MF-000013839
- Devices
- 4
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Synergie Nederland makes
Synergie Nederland manufactures specialized pressure-relieving support surfaces for patient care, including bed units and control units designed to manage wound treatment and prevent complications. Their product line includes the AFCS SANDS (SAT1) and AFCS PEARLS™ systems, which combine bed units with dedicated control units for adjustable pressure management.
These devices fall under EU Class IIb classification and are registered in the EUDAMED database. The company operates from the Netherlands, adhering to regulatory requirements for medical devices within the European Union.
Catalogue
AFCS SANDS (SAT1) Bed unit Ref 1010403
CE MDR EUDAMEDAFCS PEARLS™ (SAT2) Control Unit Ref 2010002
CE MDR EUDAMEDAFCS PEARLS™ Bed Unit Ref 2010003
CE MDR EUDAMEDAFCS SANDS (SAT1) Control unit Ref 1010402
CE MDR EUDAMED
Company details
- EUDAMED SRN
- NL-MF-000013839
- EU VAT number
- NL009915333B01
- EUDAMED status
- Active
- EUDAMED registered name
- Synergie Nederland
- EUDAMED abbreviated name
- Synergie
- Registered address
- 6, Sterrekroos, 4941 VZ, RAAMSDONKSVEER, Netherlands
- Website
- www.synergiecare.com
- [email protected]
- Phone
- +31162570055
- PRRC contact
- Ger Bouwens
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Nov 2029
Notified body 0344 1 certificate
- 2259705CE01 Issued
Quality management system EU MDR
- Issued
- 5 Nov 2024
- Expires
- 1 Nov 2029
From the company website
At Synergie we understand the kind of support surface that is needed to optimize the treatment of wounds as well as to prevent complications. To avoid uncertainties which could increase the risk of mortality or extend the treatment period unnecessarily .
Frequently asked questions
How many devices does Synergie Nederland have in the registry?
The registry currently lists 4 devices for Synergie Nederland. Devices recorded under merged duplicate company entries are counted once.
Which registries list Synergie Nederland's devices?
Among its 4 most recently registered devices, Synergie Nederland has devices listed in EUDAMED (4 devices).
What risk classes do Synergie Nederland's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Synergie Nederland's devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Synergie Nederland?
EUDAMED lists 1 certificate for Synergie Nederland (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2024-11-05.
What are the newest devices from Synergie Nederland in the registry?
The most recently registered devices listed for Synergie Nederland include AFCS SANDS (SAT1) Bed unit, AFCS PEARLS™ (SAT2) Control Unit, AFCS PEARLS™ Bed Unit and AFCS SANDS (SAT1) Control unit.