ELERA

GUDID 16939184600359

Blood Glucose Test Strips

Bioland Technology Ltd.

Glucose monitoring system IVD, home-use
Primary Device ID16939184600359
NIH Device Record Key4791f8cd-1392-4e96-ad80-9d85569df1df
Commercial Distribution StatusIn Commercial Distribution
Brand NameELERA
Version Model NumberG-427BS
Company DUNS545852548
Company NameBioland Technology Ltd.
Device Count1
DM Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106939184600352 [Primary]
GS116939184600359 [Package]
Contains: 06939184600352
Package: [20 Units]
In Commercial Distribution
GS126939184600356 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-23
Device Publish Date2023-08-15

On-Brand Devices [ELERA]

16939184630479Blood Glucose Monitoring System
16939184600359Blood Glucose Test Strips

Trademark Results [ELERA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELERA
ELERA
90885500 not registered Live/Pending
Inmarsat Global Limited
2021-08-16
ELERA
ELERA
90465634 not registered Live/Pending
Toshiba Global Commerce Solutions, Inc.
2021-01-14
ELERA
ELERA
88883813 not registered Live/Pending
Ningbo Zhenhe Electric Co., Ltd
2020-04-23
ELERA
ELERA
87215732 5754223 Live/Registered
WANG WEI
2016-10-26
ELERA
ELERA
86817420 5085144 Live/Registered
Wang Wei
2015-11-12

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