AlphagoMed Yes
GUDID 16953825909625
Shenzhen Urion Technology Co., Ltd
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist| Primary Device ID | 16953825909625 |
| NIH Device Record Key | 880575a8-7fc0-4358-a253-e2fe62d9d682 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AlphagoMed |
| Version Model Number | U80EH |
| Catalog Number | Yes |
| Company DUNS | 421294358 |
| Company Name | Shenzhen Urion Technology Co., Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06953825909628 [Primary] |
| GS1 | 16953825909625 [Package] Contains: 06953825909628 Package: Carton [40 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K243115
FDA Product Code
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-28 |
| Device Publish Date | 2025-04-18 |
On-Brand Devices [AlphagoMed]
| 06953825904593 | U81H |
| 06953825903435 | U80H |
| 06953825903169 | U60EH |
| 06953825903152 | U60CH |
| 06953825903145 | U80R |
| 06953825903138 | U80EH |
| 06953825904883 | U80E |
| 06953825909024 | U807 |
| 06953825903671 | U80K |
| 06953825903756 | U82H |
| 06953825903978 | U80U |
| 06953825904067 | U80RH |
| 06953825909055 | U81NH |
| 06953825909369 | U80M |
| 06953825907310 | U60BH |
| 06953825905323 | U80M |
| 06953825905859 | U80T |
| 16953825908840 | U80EH |
| 16953825909632 | UFR102 |
| 16953825909625 | U80EH |
| 16953825909618 | U80EH |
| 16953825909649 | U83Z |
| 16953825906730 | U87E |
Trademark Results [AlphagoMed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALPHAGOMED 87374900 5363227 Live/Registered |
SHENZHENÂ URIONÂ TECHNOLOGYÂ CO.,LTD 2017-03-17 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.