Data / Medical devices / Singapore / Medipurpose Pte. Ltd.
Medipurpose Pte. Ltd.: FDA-registered device maker in SINGAPORE Central Singapore, Singapore, 2 510(k) clearances
Medipurpose Pte. Ltd. is registered with the FDA (registration 9614157) in SINGAPORE Central Singapore, Singapore. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 30, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9614157
- FEI number
- 3008179438
- Address
- 10 Anson Road No. 12-08 International Plaza, SINGAPORE Central Singapore, Singapore, 079903
- Owner or operator
- MEDIPURPOSE PTE LTD (9036485)
- Roles
- Exporter to the US, Foreign private label distributor, Specification developer
- First device listed
- March 2, 2016
- Registered through
- 2027
- Brand names listed
- Anzen Safety Scalpel Cartridge, Anzen Safety Scalpel Handle, SurgiLance Lite Safety Lancet, surgiLance Safety Lancet
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blade, Scalpel | GES | 1 | Exporter to the US, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US, Foreign private label distributor, Specification developer | 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 30, 2022 | K222090 | Safety Lancet | FMK | Substantially Equivalent | Ningbo Medsun Medical Co., Ltd. | accessdata.fda.gov |
| September 22, 2022 | K222224 | SurgiLance® Safety Lancet | FMK | Substantially Equivalent | Medipurpose Pte. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Handle, Scalpel
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Blade, Scalpel
Updated September 30, 2022. 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.