| Primary Device ID | 05907642694534 |
| NIH Device Record Key | fecf771c-fc24-4a4e-b0d4-343ec4dc2224 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Refraction Unit |
| Version Model Number | EASY |
| Company DUNS | 366126408 |
| Company Name | MDT SP Z O O |
| 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 | true |
| 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 | 05907642694534 [Primary] |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-24 |
| Device Publish Date | 2025-07-16 |
| 05907642694442 | UNIQ |
| 05907642694596 | TRU-2000 |
| 05907642694589 | TRU-1000 |
| 05907642694565 | TRU-800 |
| 05907642694541 | SMART PLUS |
| 05907642694534 | EASY |
| 05907642694510 | ECO PLUS |
| 05907642694497 | TRU-2500 |
| 05907642694480 | PRO 1000 EVO |
| 05907642694473 | PRO 1000 |
| 05907642694466 | PRO 500 |
| 05907642694459 | EASY PLUS |
| 05907642694435 | TOROS |