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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Instruments to support and monitor vital signs
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Vital signs monitoring instruments
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Multi–parameter patient monitors
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Multi–parameter patient bedside monitors
Multi–parameter patient bedside monitors
Z1203020201
798 devices
UbiqVue 1AX Wearable Biosensor
LifeSignals, Inc.
·
,
United States
Class IIb
CE/MDR
GUDID
on market
patient monitor
Guangdong Biolight Meditech Co., Ltd
·
,
China
Class IIb
CE/MDR
Patient Monitor
Shenzhen Witleaf Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
HS Fixing Base
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
GUDID
on market
Lithium-ion Battery Pack
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
GUDID
on market
TruSkan S600
Skanray Technologies Private Limited
·
,
India
Class IIb
CE/MDD
Module Connection Cable
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
GUDID
on market
NMT Module
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
Patient Monitor
Edan Instruments, Inc.
·
,
China
Class IIb
FDA 510(k)
×2
K220308
Active
Cleared 11 Aug 2022
CE/MDR
+1
authorizations
Patient Monitor
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
·
,
China
Class IIb
CE/MDD
Patient Monitor
Open recall
Edan Instruments, Inc.
·
,
China
Class IIb
FDA 510(k)
×8
K110922
Active
Cleared 20 Jul 2011
CE/MDR
+1
authorizations
Unit Connection Cable
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
GUDID
on market
Multi-parameter patient monitor
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIb
CE/MDR
Patient Monitor
Shenzhen Witleaf Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
Patient Monitor
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
Patient Monitor
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
Storage Box for Trolley
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
Multi-parameter patient monitor
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIb
CE/MDR
Display Unit Connection Cable
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
GUDID
on market
Patient Monitor
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIb
CE/MDR
GUDID
on market
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