FDA Registration
Active
🇧🇬 Bulgaria
Arm Abduction Orthosis, Dynamic
Reg #: 3018070833
·
FEI: 3018070833
·
Expires 2025
Products
1
Proprietary Names
19
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 |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2014-05-05 |
Proprietary Names
Arm Abduction Orthosis, Dynamic
Arm Abduction Orthosis Acro Assist
UD Tennis Elbow Sleeve
UD X-Stable Shoulder Brace
UD Tennis Elbow Strap
X-RX Elbow Support
PRN Original Elbow Pad
PRN Elbow Pad Jr
QD Wrist & Thumb Support
UD Hyper-X Elbow Brace
PRN Elbow Pad
QD Shoulder Support
X-RX Wrist Support
RX Elbow Sleeve
QD Elbow Sleeve
QD Forearm Sleeve 1,5mm Pair Black
PRN Original Elbow Pad Jr
RX Original Elbow Sleeve
Epi Forsa Plus
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)