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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
Freestyle Comfort
Caire Inc.
·
,
United States
Class IIa
CE/MDD
JLO-590Si, Galena
Shenzhen Homed Medical Device Co., Ltd.
·
,
China
Class IIb
CE/MDR
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
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
Portable Medical Oxygen Concentrator
Shenyang RMS Medical Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Sümer
Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
·
,
Türkiye
Class IIb
CE/MDD
NewLife Intensity 10
Caire Inc.
·
,
United States
Class IIa
CE/MDD
Oxygen Concentrator
Oxytek Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDD
FDA 510(k)
K252965
Active
Cleared 29 May 2026
+2
authorizations
oxygen concentrator
Awatar Medical Aid d.o.o.
·
,
Croatia
Class IIa
CE/MDR
Oxygen Concentrator
Famidoc Technology Company Limited
·
,
China
Class IIa
CE/MDR
Oxygen Concentrator for Medical Use
Shenyang Canta Medical Tech.Co., Ltd
·
,
China
Class IIb
CE/MDR
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE
Oxygen Concentrator
Famidoc Technology Company Limited
·
,
China
Class IIa
CE/MDR
Oxygenate
Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.
·
,
China
Class IIa
CE/MDD
Oxygen Concentrator
Famidoc Technology Company Limited
·
,
China
Class IIa
CE/MDR
Mark 5 Nuvo Lite
Nidek Medical Products Inc.
·
,
United States
Class IIb
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
Sümer
Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
·
,
Türkiye
Class IIb
CE/MDD
Oxygen Concentrator
Guangzhou Life Light Electronic Technology Co., Ltd.
·
,
China
Class IIa
CE/MDD
Max 30
Nidek Medical Products Inc.
·
,
United States
Class IIb
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
Oxygen concentrator
Beijing Choice Electronic Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
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