| Primary Device ID | 06974849369403 |
| NIH Device Record Key | 6ce7b522-fd5f-45b5-86bc-47deabb1a130 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EudemonTM AIO800 |
| Version Model Number | HWTS-AIO800 |
| Catalog Number | HWTS-EQ055 |
| Company DUNS | 560300737 |
| Company Name | Jiangsu Macro & Micro-Test Med-Tech 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 | true |
| Expiration Date | true |
| 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 | 06974849369403 [Primary] |
| NSU | Instrumentation For Clinical Multiplex Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-22 |
| Device Publish Date | 2024-11-14 |
| 06974849369403 - EudemonTM AIO800 | 2024-11-22 |
| 06974849369403 - EudemonTM AIO800 | 2024-11-22 |
| 06974849369380 - Macro & Micro-Test Fluorescence Immunoassay Analyzer | 2024-09-27 |
| 06974849369397 - Macro & Micro-Test Fluorescence Immunoassay Analyzer | 2024-09-27 |
| 06974849369304 - Macro & Micro-Test HCG Pregnancy Test Midstream | 2023-12-05 |
| 06974849369311 - Macro & Micro-Test HCG Pregnancy Test Midstream | 2023-12-05 |
| 06974849369328 - Macro & Micro-Test HCG Pregnancy Test Midstream | 2023-12-05 |
| 06974849369335 - Macro & Micro-Test HCG Pregnancy Test Midstream | 2023-12-05 |
| 06974849369342 - Macro & Micro-Test LH Test | 2023-12-05 |