FDA Registration
Active
🇮🇹 Italy
VACUTEST KIMA SRL
Reg #: 3010280735
·
FEI: 3010280735
·
Expires 2026
Products
3
Proprietary Names
0
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- VACUTEST KIMA SRL
- Registration Number
- 3010280735
- FEI Number
- 3010280735
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VIA DELL'INDUSTRIA 12
- City
- ARZERGRANDE Padova
- Country
- IT
Regulatory Submissions
- 510(k) Number
- K200932
Owner / Operator
- Firm Name
- VACUTEST KIMA Srl
- Operator Number
- 10043026
- Address
- VIA DELL'INDUSTRIA 12
- City
- ARZERGRANDE
- State
- Padova
- Postal Code
- 35020
- Country
- IT
US Agent
- Business Name
- ISOPLAN USA
- Contact Name
- Lorenzo Da Madice
- Address
- 3408 Rexford Cir
- City
- Ormond Beach
- State
- FL
- ZIP
- 32174
- Country
- US
- [email protected]
- Phone
- 386 8680618
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-12-27 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2013-01-21 |
| Test, Erythrocyte Sedimentation Rate | JPH | Class 1 | Hematology | No | 2017-02-14 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device