Edwards Lifesciences Services GmbH
Country not established
- Devices
- 3
What Edwards Lifesciences Services GmbH makes
Edwards Lifesciences Services GmbH manufactures sterile tubing sets, including the AQUALINE and AQUALINS variants, as well as specialized hemofiltration systems like the AQUARIUS System (Model GE-F098-00) and AQUARIUS Hemofiltration System (Model ABM 01). These products are designed for medical procedures requiring controlled fluid management, such as dialysis and related therapies.
The company’s portfolio is regulated under Class II medical devices in the US, with relevant products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Edwards Aqualine Sterile Tubing Set; Edwards Aqualins Sterile Tubing Set; Edwards Aquaspike And Aquasafe Ref K063293
Regimes: 510(k) Registry: 510(k)Edwards Aquarius System, Model Ge-F098-00 Ref K090682
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Edwards Lifesciences Services GmbH have in the registry?
The registry currently lists 3 devices for Edwards Lifesciences Services GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edwards Lifesciences Services GmbH's devices?
Among its 3 most recently registered devices, Edwards Lifesciences Services GmbH has devices listed in FDA 510(k) (3 devices).
What risk classes do Edwards Lifesciences Services GmbH's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Edwards Lifesciences Services GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Edwards Lifesciences Services GmbH in the registry?
The most recently registered devices listed for Edwards Lifesciences Services GmbH include EDWARDS AQUALINE STERILE TUBING SET; EDWARDS AQUALINS STERILE TUBING SET; EDWARDS AQUASPIKE AND AQUASAFE, EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 and EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01.