Endo Twinn B.V.
NetherlandsFDA applicant, unverified
- Devices
- 2
What Endo Twinn B.V. makes
Endo Twinn B.V. manufactures disposable endoscopic accessories, including the DOWN PAK and ENDO TWINN, designed for single-use procedures in gastrointestinal endoscopy. These products are intended for use with endoscopes to facilitate insertion, retrieval, or manipulation of instruments during diagnostic or therapeutic procedures.
The company’s portfolio is classified under Class I medical devices in the US and is listed in the FDA 510(k) registry. The devices are regulated under the US Food and Drug Administration’s requirements for low-risk, non-invasive or minimally invasive products. The manufacturer is based in the United States.
Catalogue
Down Pak Ref K070246
Regimes: 510(k) Registry: 510(k)Endo Twinn Ref K042870
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Endo Twinn B.V. have in the registry?
The registry currently lists 2 devices for Endo Twinn B.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Endo Twinn B.V.'s devices?
Among its 2 most recently registered devices, Endo Twinn B.V. has devices listed in FDA 510(k) (2 devices).
What risk classes do Endo Twinn B.V.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Endo Twinn B.V.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Endo Twinn B.V. in the registry?
The most recently registered devices listed for Endo Twinn B.V. include DOWN PAK and ENDO TWINN.