FDA Registration
Active
🇺🇸 United States
Enzol (2252, 2257), Cidezyme (2258, 2260), Cidezyme XTRA (22591 ) AEROZYME XTRA (22520)
Reg #: 2084725
·
FEI: 3003662624
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ADVANCED STERILIZATION PRODUCTS
- Registration Number
- 2084725
- FEI Number
- 3003662624
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 33 TECHNOLOGY DRIVE
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Owner / Operator
- Firm Name
- Advanced Sterilization Products
- Operator Number
- 9068155
- Address
- 33 Technology Drive, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Brent Lewis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2021-02-11 |
Proprietary Names
Enzol (2252, 2257), Cidezyme (2258, 2260), Cidezyme XTRA (22591 ) AEROZYME XTRA (22520)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility