Data / Medical devices / Germany / Kessel Medintim GMBH
Kessel Medintim GMBH: FDA-registered device maker in Morfelden-Walldorf Hesse, Germany, 1 510(k) clearance
Kessel Medintim GMBH is registered with the FDA (registration 3011014178) in Morfelden-Walldorf Hesse, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 26, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011014178
- Address
- Kelsterbacher Str. 28, Morfelden-Walldorf Hesse, Germany, 64546
- Owner or operator
- Kessel medintim GmbH (10048803)
- Roles
- Manufacturer
- First device listed
- March 3, 2015
- Registered through
- 2026
- Brand names listed
- Active3 Erection System, Caya contoured diaphragm, Constriction ring 12 mm, Constriction ring 15mm, Constriction ring 18mm, Constriction ring 21mm, Constriction ring 9mm, Manual Erection System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Penile | FHA | 1 | Manufacturer | accessdata.fda.gov |
| Device, External Penile Rigidity | LKY | 2 | Manufacturer | accessdata.fda.gov |
| Diaphragm, Contraceptive (And Accessories) | HDW | 2 | Manufacturer | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 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 |
|---|---|---|---|---|---|---|
| August 26, 2014 | K140305 | CAYA CONTOURED DIAPHRAGM | HDW | Substantially Equivalent | Kessel Medintim GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Device, External Penile Rigidity
- All makers of Clamp, Penile
- All makers of Dilator, Cervical, Fixed Size
- All makers of Diaphragm, Contraceptive (And Accessories)
Updated August 26, 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.