FDA Registration
Active
🇩🇪 Germany
EcoBalloon OBT RA-S
Reg #: 9611612
·
FEI: 3002807847
·
Expires 2025
Products
1
Proprietary Names
20
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
- K012771
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 | 2014-08-27 |
Proprietary Names
EcoBalloon OBT RA-S
TrocaTec AUTO
TrocaObt PROTECT
EcoBalloon OBT DIL
TrocaObt CONE
EcoBalloon TrocaPort
TrocaObt SHIELD
TrocaTec MAN
EcoBalloon OBT PROTECT
EcoBalloon OBT RA
EcoBalloon TrocaTec MAN
TrocaPort TOP
TrocaPort SLEEVE
Hasson cone
TrocaObt HASSON
EcoBalloon TrocaTec AUTO
TrocaObt PYRAMID
EcoBalloon OBT SB
TrocaTube
TrocaPort
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device