Data / Medical devices / Germany / Mavig GMBH
Mavig GMBH: FDA-registered device maker in MUNICH Bavaria, Germany, 2 510(k) clearances
Mavig GMBH is registered with the FDA (registration 9680506) in MUNICH Bavaria, Germany. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 21, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680506
- FEI number
- 3002939620
- Address
- Stahlgruberring 5, MUNICH Bavaria, Germany, 81829
- Owner or operator
- MAVIG GmbH (9009516)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- February 7, 1994
- Registered through
- 2026
- Brand names listed
- BR - X-Ray Protection for Eyes, GR - Radiation Protective Shields, LE - Portegra2 Lamps, LEO - surgical lights (including Portegra), OT - Radiation Protection Shields for Overhead Suspensions, RA - X-Ray Protective Clothing for Radiation Exposure (Operator), RD - X-Ray Protection Clothing for Radiation Exposure (Dental), RD - X-Ray Protective Clothing for Radiation Exposure (Dental) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apron, Leaded | EAJ | 1 | Manufacturer | accessdata.fda.gov |
| Apron, Protective | IWO | 1 | Manufacturer | accessdata.fda.gov |
| Barrier, Control Panel, X-Ray, Movable | IWX | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Device, Medical Examination, Ac Powered | KZF | 1 | Exporter to the US | accessdata.fda.gov |
| Light, Surgical, Ceiling Mounted | FSY | 2 | Exporter to the US | accessdata.fda.gov |
| Screen, Leaded, Operator Radiation Protector | EAK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Shield, Eye, Radiological | IWS | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Gonadal | IWT | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | 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 |
|---|---|---|---|---|---|---|
| November 21, 2006 | K063333 | M3 | FSY | Substantially Equivalent | Mavig GmbH | accessdata.fda.gov |
| November 30, 2004 | K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | MMP | Substantially Equivalent | Guangzhou Fortunique , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Apron, Leaded
- All makers of Screen, Leaded, Operator Radiation Protector
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Apron, Protective
- All makers of Cover, Barrier, Protective
- All makers of Device, Medical Examination, Ac Powered
Updated November 21, 2006. 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.