FDA Registration
Active
🇩🇪 Germany
Integra NeuroBalloon Catheter
Reg #: 3002807090
·
FEI: 3006003617
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics Germany GmbH
- Registration Number
- 3002807090
- FEI Number
- 3006003617
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kasteler Straße 45
- City
- Wiesbaden Hesse
- Country
- DE
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-06-28 |
Proprietary Names
Integra NeuroBalloon Catheter
Ad-Tech Obturators
Wyler Transector
KROLMAN INSTRUMENT
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)