FDA Registration
Active
🇩🇪 Germany
asap Cystoscope
Reg #: 3008494403
·
FEI: 3008494403
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- asap endoscopic products GmbH
- Registration Number
- 3008494403
- FEI Number
- 3008494403
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Stoeckmatten19
- City
- Umkirch Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K031141
Owner / Operator
- Firm Name
- asap GmbH
- Operator Number
- 10023512
- Address
- asap endoscopic products GmbH, Stoeckmatten19
- City
- Umkirch
- State
- Baden-Wurttemberg
- Postal Code
- 79224
- Country
- DE
- Correspondent
- Horst Baholzer
US Agent
- Business Name
- Point Medical LLC
- Contact Name
- John Rafols
- Address
- 102 Stone Point Court
- City
- Mooresville
- State
- NC
- ZIP
- 28117
- Country
- US
- [email protected]
- Phone
- 704 6608372
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2007-11-28 |
Proprietary Names
asap Cystoscope
asap Oesophagoscope
asap Laryngoscope
asap Laparoscope
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device