Andreas Pein Medizintechnik GmbH
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- Devices
- 1
What Andreas Pein Medizintechnik GmbH makes
Andreas Pein Medizintechnik GmbH manufactures the HELIX HYDRO-JET, a device designed for hydro-jet lavage in medical procedures, likely used for cleaning or irrigating wounds or surgical sites.
The HELIX HYDRO-JET is classified as a Class II medical device and is listed under the FDA’s 510(k) premarket notification process. The company is based in the United States.
Catalogue
Helix Hydro-Jet Ref K012464
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Andreas Pein Medizintechnik GmbH have in the registry?
The registry currently lists 1 device for Andreas Pein Medizintechnik GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Andreas Pein Medizintechnik GmbH's devices?
Among its 1 most recently registered device, Andreas Pein Medizintechnik GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Andreas Pein Medizintechnik GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Andreas Pein Medizintechnik GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Andreas Pein Medizintechnik GmbH in the registry?
The most recently registered devices listed for Andreas Pein Medizintechnik GmbH include HELIX HYDRO-JET.