FDA Registration
Active
🇿🇦 South Africa
Synergy Sterilisation South Africa Proprietary Ltd
Reg #: 3010287685
·
FEI: 3010287685
·
Expires 2026
Products
16
Proprietary Names
9
Establishment Types
1
Classifications
16
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Registration Details
- Registration Name
- Synergy Sterilisation South Africa Proprietary Ltd
- Registration Number
- 3010287685
- FEI Number
- 3010287685
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5 Waterpas Street, Isando Ext 3 Kempton Park 1620
- City
- Isando Gauteng
- Country
- ZA
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 4687462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2019-12-09 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2015-09-18 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2013-01-24 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-12-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-09-05 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-09-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-09-05 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-09-05 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2014-09-05 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-09-05 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2019-12-09 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2019-12-09 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2013-01-24 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2019-12-09 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-11-21 |
Proprietary Names
Molnlycke (KK,VL) - Lyofoam Max
FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive
Molnlycke (KK,VL) - Lyofoam Dressings
FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive
FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive
FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive
AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing
FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive
FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)