FDA Registration
Active
🇸🇬 Singapore
CARTO VIZIGO 8.5F Bi -Directional Guiding Sheath
Reg #: 3021951050
·
FEI: 3021951050
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- QUASAR MEDICAL (SINGAPORE) PTE. LTD.
- Registration Number
- 3021951050
- FEI Number
- 3021951050
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8 Admiralty Street, 07-10 Admirax
- City
- Singapore North West
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K170997
Owner / Operator
- Firm Name
- Quasar Medical (Singapore) Pte. Ltd.
- Operator Number
- 10085394
- Address
- 8 Admiralty Street, 07-10 Admirax
- City
- Singapore
- State
- SG-NOTA
- Postal Code
- 757438
- Country
- SG
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2025-02-14 |
Proprietary Names
CARTO VIZIGO 8.5F Bi -Directional Guiding Sheath
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)