Haselmeier GmbH
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Haselmeier GmbH makes
Haselmeier GmbH manufactures insulin delivery devices, including prefilled insulin pens such as the TACTIPEN and HASELMEIER PEN 8, designed for subcutaneous administration of insulin in diabetes management.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Tactipen Ref K083457
Regimes: 510(k) Registry: 510(k)Haselmeier Pen 8 Ref K082616
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Haselmeier GmbH STUTTGART Baden-Wurttemberg · DE FEI 3007193283
Frequently asked questions
How many devices does Haselmeier GmbH have in the registry?
The registry currently lists 2 devices for Haselmeier GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haselmeier GmbH's devices?
Among its 2 most recently registered devices, Haselmeier GmbH has devices listed in FDA 510(k) (2 devices).
What risk classes do Haselmeier GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Haselmeier GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Haselmeier GmbH in the registry?
The most recently registered devices listed for Haselmeier GmbH include TACTIPEN and HASELMEIER PEN 8.
Which FDA establishments are linked to Haselmeier GmbH?
1 FDA establishment is linked to Haselmeier GmbH in the registry; they are listed on the company page.