FDA Registration
Active
🇮🇹 Italy
STERIS SPA
Reg #: 3002806603
·
FEI: 3002806603
·
Expires 2025
Products
5
Proprietary Names
0
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- STERIS SPA
- Registration Number
- 3002806603
- FEI Number
- 3002806603
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3, 5, 7, 9, VIA EINAUDI
- City
- CALCINATE Bergamo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K153743
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10042227
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
US Agent
- Business Name
- Synergy Health
- Contact Name
- Becky Aldhizer
- Address
- 5960 Heisley Rd
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
- [email protected]
- Phone
- 440 3927490
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2019-03-04 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-03-04 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2019-03-04 |
| Instrument, Surgical, Sonic And Accessory/Attachment | JDX | Class 2 | Orthopedic | No | 2019-03-04 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2019-03-04 |
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)