| Primary Device ID | 00853858006324 |
| NIH Device Record Key | 15ab7314-8336-400c-98d1-4ed1067eff95 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Empatica E4 |
| Version Model Number | E4 |
| Catalog Number | E4 |
| Company DUNS | 430141750 |
| Company Name | EMPATICA SRL |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853858006324 [Primary] |
| GZO | Device, Galvanic Skin Response Measurement |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-08 |
| Device Publish Date | 2021-09-30 |
| 00853858006232 - Empatica Health Monitoring Platform | 2022-12-02 |
| 00853858006249 - Empatica Health Monitoring Platform | 2022-12-02 |
| 00853858006256 - Empatica Health Monitoring Platform | 2022-12-02 |
| 00853858006263 - Empatica Health Monitoring Platform | 2022-12-02 |
| 00853858006324 - Empatica E4 | 2021-10-08 |
| 00853858006324 - Empatica E4 | 2021-10-08 |
| 00853858006102 - Embrace2 | 2020-02-19 |
| 00853858006119 - Embrace2 | 2020-02-19 |
| 00853858006126 - Embrace2 | 2020-02-19 |