FDA Registration
Active
🇮🇹 Italy
HMIX42 standard version
Reg #: 3014345398
·
FEI: 3014345398
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DELCON SRL
- Registration Number
- 3014345398
- FEI Number
- 3014345398
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Zanica 19/F/I
- City
- Grassobbio Bergamo
- Country
- IT
Regulatory Submissions
- 510(k) Number
- BK190429
Owner / Operator
- Firm Name
- Delcon Srl
- Operator Number
- 10057182
- Address
- Via Zanica 19/F/I
- City
- Grassobbio
- State
- Bergamo
- Postal Code
- 24050
- Country
- IT
- Correspondent
- Fabio Belletti
US Agent
- Business Name
- ISOplan USA
- Contact Name
- Lorenzo Da Madice
- Address
- 1 Festiva at Lionspaw
- City
- Daytona Beach
- State
- FL
- ZIP
- 32124
- Country
- US
- [email protected]
- Phone
- 386 8680618
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Mixing And Weighing, Semi-Automated | MYJ | Class 2 | Hematology | No | 2020-02-26 |
Proprietary Names
HMIX42 standard version
HMIX41 RFID version
HMIX4.21 RFID version (white/red shell)
HMIX4.22 standard version (white/red shell)
HMIX4.32 Milano standard version (white/grey)
HMIX4.31 Milano RFID version (white/grey)
Establishment Types
Manufacture Medical Device