FDA Registration
Active
🇨🇭 Switzerland
ASP Global Manufacturing GmbH
Reg #: 3015392401
·
FEI: 3015392401
·
Expires 2026
Products
9
Proprietary Names
20
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- ASP Global Manufacturing GmbH
- Registration Number
- 3015392401
- FEI Number
- 3015392401
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Im Majorenacker 10
- City
- SCHAFFHAUSEN
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K163598
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
US Agent
- Business Name
- ADVANCED STERILIZATION PRODUCTS
- Contact Name
- Brent Lewis
- Address
- 33 Technology Drive, --
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 425 2177539
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2017-08-21 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2017-08-21 |
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2008-01-10 |
| Sterilizer, Chemical | MLR | Class 2 | General Hospital | No | 2008-01-10 |
| Sterilizer, Ethylene-Oxide Gas | FLF | Class 2 | General Hospital | No | 2008-05-06 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2026-04-16 |
| Accessories, Cleaning, For Endoscope | FEB | Class 2 | Gastroenterology, Urology | No | 2019-05-07 |
| Biological Sterilization Indicator With Indirect Growth Detection | QVB | Class 2 | General Hospital | No | 2026-04-16 |
| A Chemical Vapor Sterilization Multivariable Chemical Indicator | QKM | Class 2 | General Hospital | No | 2026-04-16 |
Proprietary Names
Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX)
Cidex OPA (20390)
CIDEX OPA Concentrate
STERRAD 100NX Sterilizer and Cassette (10104, 10104-002, 10144)
STERRAD NX System w ALLClear Technology (10133, 10033ACSW, 10033-004)
STERRAD 100S Sterilizer and Cassette (10101, 10113)
BIOTRACE Instant Read Steam PCD (73140)
BIOTRACE VERISURE and SEALSURE Indicators and Readers
STERRAD NX and 100NX with DTI Connectivity (DTINX, DTI100NX)
STERRAD 100NX w ALLClear Technology (10144, 10104ACSW, 10104-005,-006,-007,-008)
CIDEX OPA Test Strips (2920, 2927, 20392, 20393)
AEROFLEX AER, AUTOSURE MRC Reagent, AEROZYME and AERO-OPA (28000, 23300, 25520, 25410)
BIOTRACE Instant Read BI (73110)
BIOTRACE Instant Read Reader (73430)
VERISURE CI Strip (73250)
VERISURE CI Strip (73260)
VERISURE CI Strip (73350)
STERRAD NX Cassette (10133)
STERRAD 100NX System DUO Cycle Upgrade Kit (10144, 10104, 10104-002,003,004)
STERRAD 100NX System EXPRESS Cycle (10144,10104,10104-002)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device