Data / Medical devices / Indonesia / PT Dongbang Medical Indonesia
PT Dongbang Medical Indonesia: FDA-registered device maker in Pekalongan Jawa Tengah, Indonesia, 1 510(k) clearance
PT Dongbang Medical Indonesia is registered with the FDA (registration 3044829319) in Pekalongan Jawa Tengah, Indonesia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 4, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044829319
- Address
- Jl Sadem, RT/RW. 01/03, Desa Tenggengwetan Kec.Siwalan, Pekalongan Jawa Tengah, Indonesia, 51154
- Owner or operator
- PT Dongbang Medical Indonesia (10095775)
- Roles
- Manufacturer
- First device listed
- April 27, 2026
- Registered through
- 2026
- Brand names listed
- DBC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Acupuncture, Single Use | MQX | 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 |
|---|---|---|---|---|---|---|
| May 4, 1999 | K990328 | DBC, DONG BANG ACUPUNCTURE NEEDLES | MQX | Substantially Equivalent | Morning Star, Dong Bang Acupuncture U.S.A., Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 4, 1999. 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.