FDA Registration
Active
🇩🇪 Germany
Neptun B - Longterm Surgical Shoe with wide outsole and especially high volume
Reg #: 8010401
·
FEI: 5812
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STREIFENEDER ortho.production gmbH
- Registration Number
- 8010401
- FEI Number
- 5812
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- MOOSFELDSTRASSE 10
- City
- EMMERING Bavaria
- Country
- DE
Owner / Operator
- Firm Name
- Streifeneder ortho.production GmbH
- Operator Number
- 8010401
- Address
- MOOSFELDSTRASSE 10, --
- City
- EMMERING, BAVARIA
- State
- DE-BY
- Postal Code
- 82275
- Country
- DE
US Agent
- Business Name
- Fabtech Systems LLC.
- Contact Name
- Greg Mattson
- Address
- 3304 Hill Avenue
- City
- Everett
- State
- WA
- ZIP
- 98201
- Country
- US
- [email protected]
- Phone
- 425 3499557
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2018-06-18 |
Proprietary Names
Neptun B - Longterm Surgical Shoe with wide outsole and especially high volume
Venus - Partial Foot Decompression Shoe, short version
Pluto S - Partial Foot Decompression Shoe (Post-Surgical Shoe)
Uranus - Partial Foot Decompression Shoe (Post-Surgical Shoe)
Luna - Longterm Surgical Shoe with 3 removable cushioning soles and reinforced outsole
Merkur - Forefoot Relief Shoe
Saturn - Forefoot Relief Shoe
Apollo - Partial Foot Decompression Shoe with zero-heel technology
Mars S - Heel Relief Shoe
Merkur A - Partial Foot Decompression Shoe (Post-Surgical Shoe)
Jupiter - Forefoot Relief Shoe
Mars - Heel Relief Shoe
Komet - Especially low Partial Foot Decompression Shoe in outdoor-design
Neptun - Longterm Surgical Shoe
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device