FDA Registration
Active
🇩🇪 Germany
FRANZ KALFF GMBH
Reg #: 3002801783
·
FEI: 3002801783
·
Expires 2026
Products
10
Proprietary Names
16
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- FRANZ KALFF GMBH
- Registration Number
- 3002801783
- FEI Number
- 3002801783
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 85 Dechant-Wolfgarten-Strasse
- City
- Euskirchen North Rhine-Westphalia
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K102161
Owner / Operator
- Firm Name
- Franz Kalff Gmbh
- Operator Number
- 10054680
- Address
- 85 Dechant-Wolfgarten-Strasse
- City
- Euskirchen
- State
- North Rhine-Westphalia
- Postal Code
- 53881
- Country
- DE
- Correspondent
- Christof Gehlen
US Agent
- Business Name
- AJW Technology Consultants, Inc.
- Contact Name
- Jon Ward
- Address
- 11705 Boyette Road, #503
- City
- Riverview
- State
- FL
- ZIP
- 33569
- Country
- US
- [email protected]
- Phone
- 813 6452855 ext. 104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-05-25 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2017-05-24 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2017-06-17 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2017-06-17 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2017-04-13 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2017-06-17 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2017-06-17 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2017-04-13 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2017-06-17 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2017-04-13 |
Proprietary Names
Tape and bandage, adhesive
Sports Tape
Microporous Tape
First Aid Kit with Drug
Disposable Medical Bedding (Emergency Blanket)
Disposable Medical Scissors
Gauze/Sponge
Triangular Bandage
Vinyl Patient Examination Gloves
First Aid Kit
Elastic Bandage
Finger Dressing
Fixation Bandage
Cohesive Bandage
Non-woven swabs
Wound compresses/dressings
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device