Data / Medical devices / Singapore / Pharmelite Ltd
Pharmelite Ltd: FDA-registered device maker in Pemimpin Central Singapore, Singapore, 1 510(k) clearance
Pharmelite Ltd is registered with the FDA (registration 3003950102) in Pemimpin Central Singapore, Singapore. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 26, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003950102
- Address
- 63 Jalan Pemimpin No 02-07 Pemimpin Industrial Building, Pemimpin Central Singapore, Singapore, 577219
- Owner or operator
- Pharmelite (10055567)
- Roles
- Exporter to the US
- First device listed
- August 12, 2017
- Registered through
- 2026
- Brand names listed
- Spacelabs Blood Pressure Monitoring Cuff Covers
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 26, 2014 | K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE | DXN | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 26, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.