FDA Registration
Active
🇩🇪 Germany
Handle with tilting
Reg #: 9611612
·
FEI: 3002807847
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PAJUNK GMBH MEDIZINTECHNOLOGIE
- Registration Number
- 9611612
- FEI Number
- 3002807847
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KARL-HALL-STRASSE 01
- City
- GEISINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K011997
Owner / Operator
- Firm Name
- PAJUNK GmbH Medizintechnologie
- Operator Number
- 8010639
- Address
- Karl-Hall-Strasse 1
- City
- Geisingen
- State
- Baden-Wurttemberg
- Postal Code
- 78187
- Country
- DE
US Agent
- Business Name
- PAJUNK MEDICAL SYSTEMS
- Contact Name
- Marco Wohnig
- Address
- 4575 Marconi Dr.
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
- [email protected]
- Phone
- 770 7572449
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2014-08-28 |
Proprietary Names
Handle with tilting
TipHandle
Free-moving handle
FlowSys Eco HF
Handle with ratchet
FlowSys Eco+ HF
Combination handle
FlowSys Ergo HF
BigFlow
FlowSys HF Duo
ErgoFlex
FlowSys Tube
FlowSys Pistol
ErgoGrip
TipRatchet
FlowSys HF
FlowSys
FlowSys Duo
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)