Data / Medical devices / Indonesia / PT Alpha Medical Technology
PT Alpha Medical Technology: FDA-registered device maker in Kota Depok Jawa Barat, Indonesia, 1 510(k) clearance
PT Alpha Medical Technology is registered with the FDA (registration 3043603327) in Kota Depok Jawa Barat, Indonesia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 16, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043603327
- Address
- JI. Pekapuran,Curung, Kec. Tapos,Kota Depok,Jawa Barat Cimanggis. Indonesia, Kota Depok Jawa Barat, Indonesia, 16453
- Owner or operator
- PT Alpha Medical Technology (10094999)
- Roles
- Manufacturer
- First device listed
- January 13, 2026
- Registered through
- 2026
- Brand names listed
- Alpha-ject Disposable Syringe, Single-ject Single Use Auto Disable Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Syringe, Piston | FMF | 2 | 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 16, 1998 | K980078 | PENETREASE | FMF | Substantially Equivalent | P.T. Panca Pusaka Deli | accessdata.fda.gov |
Compare with other makers
Updated October 16, 1998. 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.