Aspire365 Yes

GUDID 16953825908994

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID16953825908994
NIH Device Record Key34af0924-6bd2-45d5-a228-3b59959c693b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAspire365
Version Model NumberU81D
Catalog NumberYes
Company DUNS421294358
Company NameShenzhen Urion Technology Co., Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106953825908997 [Primary]
GS116953825908994 [Package]
Contains: 06953825908997
Package: Carton [20 Units]
In Commercial Distribution

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-06
Device Publish Date2024-11-28

Devices Manufactured by Shenzhen Urion Technology Co., Ltd

16953825909304 - carda health2025-01-20
16953825909281 - VtsniMed2025-01-14
16953825909243 - EVOLUTI2025-01-13
16953825909236 - COCACIS2025-01-09
16953825909168 - N/A2024-12-26
26953825909097 - santecare2024-12-25
16953825909076 - Andesfit Health2024-12-13
16953825909083 - Tovendor2024-12-13

Trademark Results [Aspire365]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASPIRE365
ASPIRE365
98237983 not registered Live/Pending
Aspire365, LLC
2023-10-24

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.