66 Vision Tech Co., Ltd.
Manufacturer and brand owner in Suzhou, Jiangsu, China. 24 device types, 1 product catalogued.
66 Vision Tech Co., Ltd. is a private-label distributor holding a current FDA establishment registration. The registration covers Exophthalmometer, Hook, Ophthalmic and 22 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2002.
Registration
| Registered name | 66 VISION TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3003553186 |
| FEI number | 3003553186 |
| DUNS | 544800253 |
| Establishment type | Private-label distributor, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 苏州六六视觉科技股份有限公司 |
|---|---|
| Unified social credit code | 913205007205880681 |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 2, No.9 Jinfeng Road, |
| Postal code | 215005 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | Class 2 | 66 Vision Tech YZ3 Portable Slit Lamp, 66 Vision Tech Slit-Lamp Biomicrosc | 2007 | 7 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Class 1 | 66 Vision Tech Cannula | 2005 | 2 |
| Exophthalmometer | Class 1 | 66 VISION TECH YZ9 Exophthalmometer | 2017 | 6 |
| Forceps, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Forceps | 2005 | 12 |
| Hook, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Hook | 2005 | 11 |
| Instrument, Manual, Surgical, General Use | Class 1 | 66 Vision Tech Surgical Instrument | 2002 | 110 |
| Instrument, Measuring, Lens, Ac-Powered | Class 1 | 66 Vision Tech Lens, YZ Lensmeter | 2005 | 15 |
| Instrument, Measuring, Stereopsis | Class 1 | 66 Vision Tech Stereops, YZ Synoptophore | 2005 | 1 |
| Knife, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Knife | 2005 | 12 |
| Lens, Condensing, Diagnostic | Class 1 | 66 Vision Tech LENS(14D,20D,28D,40D,78D,90D) | 2021 | 6 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | Class 1 | 66 Vision Tech Microscope | 2005 | 12 |
| Monitor, Eye Movement | Class 2 | 66 Vision Tech Ophthalmoscope, YZ11E, YZ25C, YZ25B | 2007 | 2 |
| Ophthalmoscope, Battery-Powered | Class 2 | 66 Vision Tech Ophthalmoscope, YZ11E, YZ25C, YZ25B | 2007 | 11 |
| Projector, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Projector | 2005 | 11 |
| Pupillometer, Manual | Class 1 | TJ Pupllometer, 66 Vision Tech Pupillometer | 2005 | 9 |
| Retinoscope, Battery-Powered | Class 1 | Retinoscope | 2026 | 8 |
| Ring, Ophthalmic (Flieringa) | Class 1 | 66 Vision Tech Ophthalmic Ring | 2005 | 3 |
| Rongeur, Lachrymal Sac | Class 1 | 66 Vision Tech Rongeur | 2005 | 1 |
| Scissors, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Scissors | 2005 | 14 |
| Spatula, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Spatula | 2005 | 9 |
| Specula, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Specula | 2005 | 11 |
| Spoon, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Spoon | 2005 | 7 |
| Spud, Ophthalmic | Class 1 | 66 Vision Tech Ophthalmic Spud | 2005 | 4 |
| Table, Instrument, Manual, Ophthalmic | Class 1 | 66 Vision Tech Ophtha | 2005 | 5 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| 66VT | HJO | 1 |
Clearances
No clearance names 66 Vision Tech Co., Ltd. as applicant. 3 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K131711 | 2014-05-09 | HJO | Traditional | Suzhou 66 Vision Tech Co., Ltd. |
| K052599 | 2006-11-07 | HLJ | Traditional | Suzhou 66 Vision Tech Co., Ltd. |
| K033190 | 2003-12-04 | HJO | Traditional | Suzhou 66 Vision Tech Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1956 |
|---|---|
| Main products | Slit-lamp microscopes, Surgical microscopes, Microsurgical instruments, Electronic medical devices |
| Certifications | ISO9001, ISO13485, ISO14001, OHSAS18001, CE, FDA |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.