Data / Medical devices / Indonesia / PT NSP Technology Batam
PT NSP Technology Batam: FDA-registered device maker in Batu Ampar Riau, Indonesia, 2 510(k) clearances
PT NSP Technology Batam is registered with the FDA (registration 3011369203) in Batu Ampar Riau, Indonesia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011369203
- Address
- Citra Buana Centre Park Il Lot 03/Lot 01, Batu Ampar Riau, Indonesia, 29432
- Owner or operator
- PT NSP Technology Batam (10048083)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 4, 2014
- Registered through
- 2026
- Brand names listed
- SafetiCET Safety Lancet, SafetiHeel, MediHeel, Novaplus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Kit, Screening, Urine | JXA | 1 | Contract manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 24, 2022 | K221783 | SafetiCET Safety Lancet | FMK | Substantially Equivalent | Nsp Tech Pte, Ltd. | accessdata.fda.gov |
| August 22, 2022 | K221604 | SafetiHeel, MediHeel, Novaplus | FMK | Substantially Equivalent | Nsp Tech Pte, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Kit, Screening, Urine
Updated October 24, 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.