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Sign in to claim this brandHOYA MEDICAL SINGAPORE PTE. LTD.
US
Last updated May 23, 2026
What HOYA MEDICAL SINGAPORE PTE. LTD. makes
HOYA MEDICAL SINGAPORE PTE. LTD. manufactures posterior-chamber intraocular lenses, including models such as IPure, PREVUE Y, Clarisert™, iSert Intraocular Lens, and iSymm Intraocular Lens.
The company's devices are classified as Class III and are listed in the FDA UDI registry. HOYA MEDICAL SINGAPORE PTE. LTD. is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does HOYA MEDICAL SINGAPORE PTE. LTD. make?
HOYA MEDICAL SINGAPORE PTE. LTD. manufactures posterior-chamber intraocular lenses, which are devices implanted in the eye to replace the natural lens after cataract surgery. Examples of their devices include IPure, PREVUE Y, Clarisert™, iSert Intraocular Lens, and iSymm Intraocular Lens, all of which are designed for pseudophakic use.
Where is HOYA MEDICAL SINGAPORE PTE. LTD. based?
HOYA MEDICAL SINGAPORE PTE. LTD. is based in the United States, as indicated in the provided data under the COUNTRY field. This location refers to where the company is registered or headquartered for regulatory purposes, even though the name includes 'Singapore'.
Which regulatory registries list devices from HOYA MEDICAL SINGAPORE PTE. LTD.?
Devices manufactured by HOYA MEDICAL SINGAPORE PTE. LTD. are listed in the FDA UDI (Unique Device Identification) registry. This registry is used to track medical devices in the United States, and the company's inclusion means their devices have been assigned UDIs for identification and post-market surveillance.
How are the devices made by HOYA MEDICAL SINGAPORE PTE. LTD. classified?
The devices made by HOYA MEDICAL SINGAPORE PTE. LTD. are classified as Class III under the U.S. FDA regulatory framework. This classification indicates they are high-risk devices, which includes implantable lenses like posterior-chamber intraocular lenses, and requires the most stringent regulatory controls, including premarket approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 894831895
Catalogue (622)
Page 1 of 13| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IPure | B1PC (clear), +29.50D | FDA UDI | Class III | Active |
| IPure | B3PY (yellow), +19.50D | FDA UDI | Class III | Active |
| Prevue Y | PREVUE (yellow), +24.50D | FDA UDI | Class III | Active |
| Clarisert™ | CLSRT (clear), +20.00 D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 251 (yellow), +11.00D | FDA UDI | Class III | Active |
| IPure | B1PC (clear), +20.00D | FDA UDI | Class III | Active |
| iSymm Intraocular Lens | FC-60AD (clear), +13.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 250 (clear), +23.00D | FDA UDI | Class III | Active |
| IPure | B3PC (clear), +27.00D | FDA UDI | Class III | Active |
| IPure | B1PC (clear), +21.00D | FDA UDI | Class III | Active |
| IPure | B3PC (clear), +14.50D | FDA UDI | Class III | Active |
| IPure | B3PC (clear), +28.50D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 251 (yellow), +19.00D | FDA UDI | Class III | Active |
| Clarisert™ | CLSRT (clear), +26.00 D | FDA UDI | Class III | Active |
| iSymm Intraocular Lens | FC-60AD (clear), +21.50D | FDA UDI | Class III | Active |
| iSymm Intraocular Lens | FC-60AD (clear), +20.00D | FDA UDI | Class III | Active |
| IPure | B3PC (clear), +7.50D | FDA UDI | Class III | Active |
| Prevue Y | PREVUE (yellow), +20.00D | FDA UDI | Class III | Active |
| IPure | B1PC (clear), +13.00D | FDA UDI | Class III | Active |
| IPure | B1PC (clear), +21.50D | FDA UDI | Class III | Active |
| IPure | B1PC (clear), +26.00D | FDA UDI | Class III | Active |
| Prevue C | PREVUE (clear), +7.00D | FDA UDI | Class III | Active |
| IPure | B3PY (yellow), +28.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 230 (clear), +16.50D | FDA UDI | Class III | Active |
| iSymm Intraocular Lens | FY-60AD (yellow), +16.50D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 230 (clear), +14.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 231 (yellow), +29.50D | FDA UDI | Class III | Active |
| IPure | B3PC (clear), +19.00D | FDA UDI | Class III | Active |
| iSymm Intraocular Lens | FY-60AD (yellow), +28.00D | FDA UDI | Class III | Active |
| IPure | B1PY (yellow), +30.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 230 (clear), +8.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 231 (yellow), +30.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 250 (clear), +14.00D | FDA UDI | Class III | Active |
| Prevue Y | PREVUE (yellow), +16.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 231 (yellow), +14.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 231 (yellow), +23.50D | FDA UDI | Class III | Active |
| IPure | B1PY (yellow), +10.00D | FDA UDI | Class III | Active |
| IPure | B3PY (yellow), +18.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 231 (yellow), +24.00D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 251 (yellow), +17.50D | FDA UDI | Class III | Active |
| Clarisert™ | CLSRT (clear), + 9.50 D | FDA UDI | Class III | Active |
| IPure | B1PY (yellow), +10.50D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 231 (yellow), +21.00D | FDA UDI | Class III | Active |
| Prevue C | PREVUE (clear), +19.50D | FDA UDI | Class III | Active |
| iSert Intraocular Lens | 230 (clear), +27.50D | FDA UDI | Class III | Active |
| IPure | B1PY (yellow), +22.00D | FDA UDI | Class III | Active |
| Prevue Y | PREVUE (yellow), +17.50D | FDA UDI | Class III | Active |
| Prevue Y | PREVUE (yellow), +15.50D | FDA UDI | Class III | Active |
| IPure | B3PC (clear), +6.50D | FDA UDI | Class III | Active |
| Prevue C | PREVUE (clear), +21.00D | FDA UDI | Class III | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Hoya Medical Singapore Pte Ltd Singapore Central Singapore · SG FEI 3007125265