Data / Medical devices / Germany / Nawa Heilmittel GMBH
Nawa Heilmittel GMBH: FDA-registered device maker in Nurnberg, Bavaria, Germany, 3 510(k) clearances
Nawa Heilmittel GMBH is registered with the FDA (registration 3004496953) in Nurnberg, Bavaria, Germany. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated October 31, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004496953
- Address
- Ostendstrasse 100, Nurnberg, Bavaria, Germany, 90482
- Owner or operator
- NAWA, Inc (9062013)
- Roles
- Specification developer
- First device listed
- March 16, 2004
- Registered through
- 2026
- Brand names listed
- NAWA Wound Cream, NAWA Wound Spray, NAWAlution Skin and Wound Cleanser, PROPHASE Wound Cleanser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 31, 2014 | K141660 | NAWALUTION SKIN AND WOUND CLEANSER | FRO | Substantially Equivalent | Nawa Heilmittel GmbH | accessdata.fda.gov |
| October 17, 2005 | K042352 | BIODERM SCIENCES WOUND CREAM | FRO | Substantially Equivalent | Bioderm Sciences, Inc. | accessdata.fda.gov |
| June 15, 2005 | K042084 | BIODERM SCIENCES WOUND HEALING SPRAY | FRO | Substantially Equivalent | Bioderm Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 31, 2014. 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.