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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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Pneumonology and respiratory physiopathology instruments
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Various pneumology and respiratory physiopathology instruments
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Oxygen concentrators
Oxygen concentrators
Z12159004
342 devices
Portable Medical Oxygen Concentrator
Shenyang RMS Medical Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Medical Oxygen Concentrator
Shenyang Aerti Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Medical Oxygen Concentrator
Shenyang Aerti Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Oxygen Concentrator for Medical Use
Shenyang Canta Medical Tech.Co., Ltd
·
,
China
Class IIb
CE/MDR
Mark 5 Nuvo Lite 3
Nidek Medical Products Inc.
·
,
United States
Class IIb
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
GUDID
on market
Oxygen Concentrator for Medical Use
Shenyang Canta Medical Tech.Co., Ltd
·
,
China
Class IIb
CE/MDR
Companion 5
Caire Inc.
·
,
United States
Class IIa
FDA 510(k)
K121167
Active
Cleared 2 May 2012
CE/MDD
Oxygen Concentrator
Henan Olive Electronic Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
oxygen concentrator
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
·
,
China
Class IIb
CE/MDR
Oxygen Concentrators
Foshan Keyhub Electronic Industries Co., Ltd.
·
,
China
Class IIa
CE/MDD
Oxygen Concentrator
Henan Olive Electronic Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
Hikoneb Oxybreath 10L
KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi.
·
,
Türkiye
Class IIb
CE/MDD
Manual hospital bed and accessories
Jianlian Homecare Products Co., Ltd
·
,
China
Class I
CE/MDR
Saros
Caire Inc.
·
,
United States
Class IIa
CE/MDD
Inogen Rove 6
Inogen, Inc.
·
,
United States
Class IIb
FDA 510(k)
K230052
Active
Cleared 30 Jun 2023
CE/MDR
+1
authorizations
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE
Portable Medical Oxygen Concentrator
Shenyang RMS Medical Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
NewLife Intensity 10
Caire Inc.
·
,
United States
Class IIa
CE/MDD
Mark 5 Nuvo 10
Nidek Medical Products Inc.
·
,
United States
Class IIb
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
GUDID
on market
NewLife Intensity 8
Caire Inc.
·
,
United States
Class IIa
CE/MDD
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