Data / Medical devices / Germany / Franz Kalff GMBH
Franz Kalff GMBH: FDA-registered device maker in Euskirchen North Rhine-Westphalia, Germany, 1 510(k) clearance
Franz Kalff GMBH is registered with the FDA (registration 3002801783) in Euskirchen North Rhine-Westphalia, Germany. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 8, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002801783
- Address
- 85 Dechant-Wolfgarten-Strasse, Euskirchen North Rhine-Westphalia, Germany, 53881
- Owner or operator
- Franz Kalff Gmbh (10054680)
- Roles
- Exporter to the US, Specification developer
- First device listed
- April 13, 2017
- Registered through
- 2026
- Brand names listed
- Cohesive Bandage, Disposable Medical Bedding (Emergency Blanket), Disposable Medical Scissors, Elastic Bandage, Finger Dressing, First Aid Kit, First Aid Kit with Drug, Fixation Bandage and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Specification developer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Specification developer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Specification developer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Specification developer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Specification developer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Specification developer | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Specification developer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, 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 8, 2010 | K102161 | BLUE SAIL INNOVATION | LYZ | Substantially Equivalent | Shandong Blue Sail Innovation Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of First Aid Kit Without Drug
- All makers of Bandage, Elastic
- All makers of Bedding, Disposable, Medical
- All makers of Scissors, Medical, Disposable
- All makers of Fiber, Medical, Absorbent
- All makers of Gauze / Sponge,Nonresorbable For External Use
Updated October 8, 2010. 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.