FDA Registration
Active
🇦🇹 Austria
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Reg #: 3005190268
·
FEI: 3005190268
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Otto Bock Healthcare Products GmbH
- Registration Number
- 3005190268
- FEI Number
- 3005190268
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Brehmstrasse 16
- City
- Vienna Wien
- Country
- AT
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 West Great Lakes Drive
- 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 |
|---|---|---|---|---|---|
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2014-11-03 |
Proprietary Names
bebalance+ 1.6
Harmony P4 modular
Derma Protection ArmComfort
X-Soft 1.10
PAULA 1.2
ProFlex Plus short
MyoBoy
MyolinoSoft
ProFlex Plus
ElbowSoft TMR 1.4
Support Bandage
C-Soft Plus 1.10
Sliding Adapter Set
Derma ProFlex
M-Soft 1.4
Ak Suspension
Otto Bock Silicone ArmLiner
Neoprene AK Suspension
Harmony P4 modular HD
connectgo.pro
C-Soft 2.8
K-Soft 1.6
MyolinoLink
Derma ProFlex short
Derma Protection Knee Comfort
ElbowSoft 1.6
Establishment Types
Manufacture Medical Device