FDA Registration
Active
🇸🇬 Singapore
Vantive Manufacturing Pte. Ltd.
Reg #: 9612057
·
FEI: 3002806460
·
Expires 2026
Products
4
Proprietary Names
11
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Vantive Manufacturing Pte. Ltd.
- Registration Number
- 9612057
- FEI Number
- 3002806460
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 WOODLANDS INDUSTRIAL PARK D, Street 2
- City
- SINGAPORE Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K102936
Owner / Operator
- Firm Name
- Vantive US Healthcare LLC
- Operator Number
- 9038727
- Address
- 510 Lake Cook Road
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Jennifer Masek-Little
US Agent
- Business Name
- Vantive US Healthcare LLC
- Contact Name
- Jennifer Masek-Little
- Address
- 510 Lake Cook Rd
- City
- Deerfield
- State
- IL
- ZIP
- 60015
- Country
- US
- [email protected]
- Phone
- 815 3548549
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-12-10 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2024-12-10 |
| System, Peritoneal, Automatic Delivery | FKX | Class 2 | Gastroenterology, Urology | No | 2020-04-01 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-12-10 |
Proprietary Names
Solution Sets w/Capless Luer Valve
Homechoice
Integrated APD Set with Cassette 3-prong
Automated PD Set with Cassette 4-Prong
Low Recirculation Volume APD Set with Cassette
HomeChoice PRO Automated Personal Cycler
Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System
ContinuFlo Solution Set; Secondary Medication Set; Solution Set
Needle, Hypodermic, Single Lumen
Interlink
Clearlink Luer Activated Valve
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Sterilize Medical Device for Another Party (Contract Sterilizer)