Smilecare

GUDID 06953825906023

Shenzhen Urion Technology Co., Ltd

Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin Infrared patient thermometer, ear/skin
Primary Device ID06953825906023
NIH Device Record Key09557bf5-1e9e-4c4d-bc27-c012897106d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmilecare
Version Model NumberUFR106
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]
GS106953825906023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical
FLLThermometer, Electronic, Clinical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

On-Brand Devices [Smilecare ]

06953825906078U80H
06953825906061U81RH
06953825906023UFR106
06953825906016UFR101

Trademark Results [Smilecare]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMILECARE
SMILECARE
90373574 not registered Live/Pending
Jiangsu Konsung Bio-Medical Science and Technology Co.,Ltd
2020-12-10
SMILECARE
SMILECARE
76605520 2996842 Dead/Cancelled
Community Dental Services, Inc.
2004-08-04
SMILECARE
SMILECARE
76605519 2996841 Live/Registered
COAST DENTAL SERVICES, LLC
2004-08-04
SMILECARE
SMILECARE
76604636 not registered Dead/Abandoned
Community Dental Services, Inc.
2004-07-29
SMILECARE
SMILECARE
76604634 not registered Dead/Abandoned
Community Dental Services, Inc.
2004-07-29
SMILECARE
SMILECARE
74448086 1860137 Live/Registered
COAST DENTAL SERVICES, LLC
1993-10-14
SMILECARE
SMILECARE
74447064 1858859 Live/Registered
COAST DENTAL SERVICES, LLC
1993-10-14
SMILECARE
SMILECARE
74024281 not registered Dead/Abandoned
Oregon Dental Association
1990-01-29

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