FDA Registration
Active
🇸🇬 Singapore
Spacelabs Blood Pressure Monitoring Cuff Covers
Reg #: 3003950102
·
FEI: 3003950102
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PHARMELITE LTD
- Registration Number
- 3003950102
- FEI Number
- 3003950102
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 63 Jalan Pemimpin No 02-07, Pemimpin Industrial Building
- City
- Pemimpin Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K141113
Owner / Operator
- Firm Name
- Pharmelite
- Operator Number
- 10055567
- Address
- 63 Jalan Pemimpin No 02-07, Pemimpin Industrial Building
- City
- Pemimpin
- State
- SG-NOTA
- Postal Code
- 577219
- Country
- SG
US Agent
- Business Name
- Accurate Consultants Inc.
- Contact Name
- Sebastian Feye
- Address
- 3234 Ibis Street
- City
- San Diego
- State
- CA
- ZIP
- 92103
- Country
- US
- [email protected]
- Phone
- 619 5170673
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2017-08-12 |
Proprietary Names
Spacelabs Blood Pressure Monitoring Cuff Covers
Establishment Types
Export Device to the United States But Perform No Other Operation on Device