Takagi
4 catalogue numbers from Slitlamp Microscope 2ZL, listed by Takagi Seiko Co., Ltd., Japan, under Biomicroscope, Slit-Lamp, Ac-Powered. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Takagi Seiko Co., Ltd., Japan |
|---|---|
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K152535 |
| Record published | 2023-06-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Slitlamp Microscope 2ZL | In distribution | |
| Slitlamp Microscope 30GL | In distribution | |
| Slitlamp Microscope 700GL | In distribution | |
| Slitlamp Microscope 4ZL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 30 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 24 |
| Marco | Takagi Seiko Co., Ltd. | 17 |
| Gilras | U.S. Ophthalmic, L.L.C. | 16 |
| Visionix | Luneau Technology Operations | 15 |
| LED Slit Lamp | Right MFG. Co., Ltd. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 12 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 12 |
| Inami | Inami & Co., Ltd. | 11 |
| Zoom Slit Lamp | Right MFG. Co., Ltd. | 8 |
| Slit Lamp BQ 900 | Haag-Streit AG | 8 |
| PolyLock Small Bone | Fusion Orthopedics, LLC | 7 |
Showing 12 of 168. All products under Biomicroscope, Slit-Lamp, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162636 | 2017-04-14 |
| K152535 | 2016-05-26 |
| K063352 | 2007-03-13 |
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.