| Primary Device ID | 06973211070619 |
| NIH Device Record Key | a5aee4f4-0ed4-4ae2-b487-48917f02b39e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fundus Camera |
| Version Model Number | SK-650B |
| Company DUNS | 545824560 |
| Company Name | CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973211070619 [Primary] |
| PJZ | Camera, Ophthalmic, General-Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-26 |
| Device Publish Date | 2025-08-18 |
| 06973211070626 | It is an AC-powered device intended to take photographs of the fundus of eye |
| 06973211070602 | It is an AC-powered device intended to take photographs of the fundus of eye |
| 06973211070008 | This equipment adopts advanced opto-mechanical and electrical integration technology, and integr |
| 06973211071517 | SK-680C |
| 06973211071500 | SK-680B |
| 06973211070619 | SK-650B |