FDA Registration
Active
🇺🇸 United States
SYNTR HEALTH TECHNOLOGIES, INC.
Reg #: 3017791237
·
FEI: 3017791237
·
Expires 2026
Products
4
Proprietary Names
1
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- SYNTR HEALTH TECHNOLOGIES, INC.
- Registration Number
- 3017791237
- FEI Number
- 3017791237
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9120 Irvine Center Dr Ste 200
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK220723
Owner / Operator
- Firm Name
- Syntr Health Technologies, Inc.
- Operator Number
- 10079670
- Address
- 9120 Irvine Center Drive Suite 200
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Ahmed Zobi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2020-12-17 |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | Class 2 | General, Plastic Surgery | No | 2024-03-07 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2024-03-07 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2022-01-06 |
Proprietary Names
SyntrFuge System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198