Data / Medical devices / Thailand / Hoya Global Distribution Center
Hoya Global Distribution Center: FDA-registered device maker in Amphur Siracha, Chonburi Chon Buri, Thailand, 1 PMA approval
Hoya Global Distribution Center is registered with the FDA (registration 3017435679) in Amphur Siracha, Chonburi Chon Buri, Thailand. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated September 26, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017435679
- Address
- 158/13 Moo 5, Tambol NongKham, Amphur Siracha, Chonburi Chon Buri, Thailand, 20110
- Owner or operator
- HOYA MEDICAL SINGAPORE PTE LTD (10026402)
- Roles
- Exporter to the US
- First device listed
- October 13, 2008
- Registered through
- 2026
- Brand names listed
- IPure B1PC, IPure B1PY, IPure B3PC, IPure B3PY, PreVue C, PreVue Y, ezSert 254E, ezSert 255E and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intraocular Lens | HQL | 3 | Exporter to the US | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 26, 2008 | P080004 | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | HQL | 45 | October 25, 2023 | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2023. 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.