| Primary Device ID | 06956748700761 |
| NIH Device Record Key | c758864a-e2c7-48ec-9aea-61a369c3a488 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Angel Aligner |
| Version Model Number | EAB II |
| Company DUNS | 421315681 |
| Company Name | Wuxi EA Medical Instruments Technologies Limited. |
| 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 | false |
| 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 | 06956748700761 [Primary] |
| DYT | Maintainer, Space Preformed, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-12 |
| Device Publish Date | 2026-02-04 |
| 06956748701270 | EAB II |
| 06956748709443 | EAB II |
| 06956748709436 | EAB II |
| 06956748709429 | EAB II |
| 06956748702147 | EAB II |
| 06956748702062 | EAB II |
| 06956748702055 | EAB II |
| 06956748700761 | EAB II |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANGEL ALIGNER 90159611 not registered Live/Pending |
WUXI EA MEDICAL INSTRUMENTS TECHNOLOGIES LIMITED 2020-09-04 |