Data / Medical devices / Germany / Medi Se And Co. KG
Medi Se And Co. KG: FDA-registered device maker in BAYREUTH Bavaria, Germany, 1 510(k) clearance
Medi Se And Co. KG is registered with the FDA (registration 8010822) in BAYREUTH Bavaria, Germany. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 15, 1994. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8010822
- FEI number
- 4599
- Address
- Medicusstr. 1, BAYREUTH Bavaria, Germany, 95448
- Owner or operator
- MEDI SE & CO. KG (8010822)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 22, 1986
- Registered through
- 2027
- Brand names listed
- 606 MEDI ACTIVE, AC Abduction Pillow, Achimed, Assure, Venasole, Reveal, Brace Liner, CEP ortho achilles brace, CEP ortho ankle brace, CEP ortho ankle sleeve and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Specification developer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Manufacturer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Cervical-Thoracic, Rigid | IQF | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | 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 |
|---|---|---|---|---|---|---|
| June 15, 1994 | K941926 | MEDI STRUMPF | DWL | Substantially Equivalent | Medi USA, LP | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Lumbar
- All makers of Cover, Limb
- All makers of Joint, Ankle, External Brace
- All makers of Joint, Knee, External Brace
- All makers of Orthosis, Cervical-Thoracic, Rigid
- All makers of Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Updated June 15, 1994. 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.