Data / Medical devices / Germany / Advanced Medical Balloons GMBH
Advanced Medical Balloons GMBH: FDA-registered device maker in Waghaeusel Baden-Wurttemberg, Germany, 1 510(k) clearance
Advanced Medical Balloons GMBH is registered with the FDA (registration 3015237508) in Waghaeusel Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 9, 2023. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015237508
- Address
- Bruchsaler Str. 22, Waghaeusel Baden-Wurttemberg, Germany, 68753
- Owner or operator
- SAGE PRODUCTS LLC (9914017)
- Roles
- Manufacturer
- First device listed
- December 16, 2025
- Registered through
- 2027
- Brand names listed
- hygh-tec bag, hygh-tec drainage
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 9, 2023 | K221400 | hygh-tec drainage | KNT | Substantially Equivalent | Creative Balloons GmbH | accessdata.fda.gov |
Compare with other makers
Updated February 9, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.