Surgmark GmbH
GermanyFDA applicant, unverified
- Devices
- 2
What Surgmark GmbH makes
Surgmark GmbH manufactures implantable radiological image markers, including the SchurSign and SchurSign Tissue Marker, designed to enhance visibility during X-ray and imaging procedures for precise surgical planning and verification.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The company is based in the United States.
Catalogue
- Registry: GUDID
SchurSign Tissue Marker Ref K230836
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 314521564
- [email protected]
- Phone
- +4996433007404
Frequently asked questions
How many devices does Surgmark GmbH have in the registry?
The registry currently lists 2 devices for Surgmark GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgmark GmbH's devices?
Among its 2 most recently registered devices, Surgmark GmbH has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Surgmark GmbH's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Surgmark GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgmark GmbH in the registry?
The most recently registered devices listed for Surgmark GmbH include SchurSign 1.5-5 and SchurSign Tissue Marker.