FDA Registration
Active
🇺🇸 United States
ZIZION GROUP Inc.
Reg #: 3009435759
·
FEI: 3009435759
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- ZIZION GROUP Inc.
- Registration Number
- 3009435759
- FEI Number
- 3009435759
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 141 NW 20th Street, Suite G1
- City
- Boca Raton
- State
- FL
- ZIP
- 33431
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK170136
Owner / Operator
- Firm Name
- Zizion Group Inc.
- Operator Number
- 10043366
- Address
- 141 NW 20th Street, Suite G1
- City
- Boca Raton
- State
- FL
- Postal Code
- 33431
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2020-09-12 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-07-15 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-07-15 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-05-16 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2013-02-09 |
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | Class 1 | Clinical Chemistry | No | 2024-02-13 |
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2023-12-26 |
Proprietary Names
MedGeneRx PRP
RegenoSonic US-155
PulseWave
Yes PRP Kit
MedGeneRx PRP BCCT
RegenOMedix TD4B Centrifuge
NanoPen Pro
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198