Sonnheim Medikal GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Sonnheim Medikal GmbH makes
Sonnheim Medikal GmbH manufactures sterile latex surgical gloves sold under the brand names Savacare and Rogumed. These products are designed for single-use medical procedures, providing barrier protection for healthcare professionals.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed via the 510(k) pathway in the United States. The products are regulated under the jurisdiction of the FDA’s Center for Devices and Radiological Health.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sonnheim Medikal GmbH have in the registry?
The registry currently lists 1 device for Sonnheim Medikal GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sonnheim Medikal GmbH's devices?
Among its 1 most recently registered device, Sonnheim Medikal GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Sonnheim Medikal GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Sonnheim Medikal GmbH's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sonnheim Medikal GmbH in the registry?
The most recently registered devices listed for Sonnheim Medikal GmbH include STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED.