Digital Electrocardiograph

GUDID 06932562310225

Guangdong Biolight Meditech Co., Ltd.

Electrocardiograph, professional, multichannel
Primary Device ID06932562310225
NIH Device Record Key47bf9557-c2ee-486d-84e1-e1d40fc42ed3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Electrocardiograph
Version Model NumberE80
Company DUNS530120146
Company NameGuangdong Biolight Meditech 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 Batchfalse
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
GS106932562310225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-02-16

Devices Manufactured by Guangdong Biolight Meditech Co., Ltd.

06932562310355 - Fingertip Pluse Oximeter2024-04-08
06932562310362 - handheld monitor2024-04-08
06932562310317 - Fingertip Pulse Oximeter2021-11-10
06932562310324 - Fingertip Pulse Oximeter2021-11-10
06932562310348 - Fingertip Pulse Oximeter2021-07-06
06932562310331 - patient monitor2020-08-18
06932562310300 - Vital Signs Monitor2020-02-06
06932562310089 - Patient Monitor2020-02-06 The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological paramet

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