FDA Registration
Active
🇿🇦 South Africa
Synergy Sterilisation South Africa Proprietary Ltd
Reg #: 3010287685
·
FEI: 3010287685
·
Expires 2025
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Synergy Sterilisation South Africa Proprietary Ltd
- Registration Number
- 3010287685
- FEI Number
- 3010287685
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5 Waterpas Street, Isando Ext 3 Kempton Park 1620
- City
- Isando Gauteng
- Country
- ZA
Regulatory Submissions
- 510(k) Number
- K063453
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-09-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-09-05 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-09-05 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)