FDA Registration
Active
🇧🇬 Bulgaria
Low Profile LSO
Reg #: 3018070833
·
FEI: 3018070833
·
Expires 2025
Products
1
Proprietary Names
18
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ottobock Manufacturing Bulgaria EOOD
- Registration Number
- 3018070833
- FEI Number
- 3018070833
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 36 Vasil Levski Blvd.
- City
- Blagoevgrad
- Country
- BG
Owner / Operator
- Firm Name
- Ottobock SE & Co. KGaA
- Operator Number
- 8010097
- Address
- Max-Naeder-Strasse 15
- City
- Duderstadt
- State
- Lower Saxony
- Postal Code
- 37115
- Country
- DE
US Agent
- Business Name
- Otto Bock HealthCare, LP
- Contact Name
- Caleb Beck
- Address
- 3820 W. Great Lakes Dr.
- City
- Salt Lake City
- State
- UT
- ZIP
- 84120
- Country
- US
- [email protected]
- Phone
- 801 9746647
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2005-07-28 |
Proprietary Names
Low Profile LSO
SI Belt Low-Profile
Smartspine LSO Standard
Pathway LS
MAC Standard
Passport LSO
Ottobock Fulcrum LSO
Original Cybertech Low Pro 8 inch
Cybertech S.P.I.N.E. Brace
Low Profile LSO Lite
Smartspine TLSO
Comprehensive LSO
Dosi EQ X High
Smartspine LSO Low
Option 1, Option 2, Option 3
Original 10 inch Standard
Premium Plus Low-Profile
Cyber 8 inch Low-Profile LSO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)