FDA Registration
Active
🇮🇹 Italy
HLT10R
Reg #: 3010407203
·
FEI: 3010407203
·
Expires 2025
Products
1
Proprietary Names
69
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics Italy SpA
- Registration Number
- 3010407203
- FEI Number
- 3010407203
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- via Marzabotto 4
- City
- Minerbio Bologna
- Country
- IT
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2012-11-01 |
Proprietary Names
HLT10R
223CS01
COPTS10ZL
212CS05
201CS01
COPS10
COPTS-01
201CS20
HLT1F
HS1R
INFH10
COPH1
HSTND
COP-MIN
229CS01
HLNEDST
COPH10
INFS1
HS10F
223CS20
224CS20
INF-NED
224CS01
CST-S10
HST10F
CST-H1
HLNEDLT
CT50-H1
HLS10ST
222CS10
209CS20
CD178S01
200CS05
212CS01
HS1F
HS10R
HLS10LT
212CS20
202CS20
HST1R
COPS1
HST10R
200CS30
222CS01
CT50-S1
HLT10F
CST-H10
BIOASSAY DISH, LOW PROFILE PS
HST1F
CST-S1
COPTS-5
HLT1R
HLS1ST
COP-NED
200CS01
INFH1
200CS10
COPTS-10
INFS10
CD179S01
CT50-S10
202CS01
HSND
HLH1ST
CD177S01
HLS1LT
218CS20
CST-NED
201CS10
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)