FDA Registration
Active
🇺🇸 United States
AZAC Group
Reg #: 3017494520
·
FEI: 3017494520
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
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Registration Details
- Registration Name
- AZAC Group
- Registration Number
- 3017494520
- FEI Number
- 3017494520
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 17870 Castleton St STE 121
- City
- City of Industry
- State
- CA
- ZIP
- 91748
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130230
Owner / Operator
- Firm Name
- AZAC Group
- Operator Number
- 10078199
- Address
- 17870 Castleton St STE 121
- City
- City of Industry
- State
- CA
- Postal Code
- 91748
- Country
- US
- Correspondent
- Yen-Ping Shan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-10-26 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-10-26 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-10-14 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2022-02-21 |
Proprietary Names
ProtectX
ProtectX Plastic Disposable Gown
AAMI Level 3 Protective Gown
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility