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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
Oc-E100
Sysmed (China) Co., Ltd
·
,
China
Class IIa
CE/MDD
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE
Oxygen Concentrator
Henan Olive Electronic Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
Go Top Line Health 6 D2000
GasN2Itrogen S.L.
·
,
Spain
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
GUDID
on market
Go Top Line Health 15 D2000
GasN2Itrogen S.L.
·
,
Spain
Class IIb
CE/MDR
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
SimplyGo External Battery Module
Respironics Inc.
·
,
United States
Class I
CE/MDR
Portable Oxygen Concentrator
Oxytek Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDR
Medical Oxygen Concentrator
Shenyang Aerti Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Portable Oxygen Concentrator
Qingdao Kingon Medical Science and Technology Co., Ltd
·
,
China
Class IIa
CE/MDR
FI25/1008016
Active
Valid to Jun 2030
GUDID
on market
Oxygen Concentrator
Bmc Medical., Ltd.
·
,
China
Class IIb
CE/MDR
Horizon
Scaleo Medical
·
,
France
Class IIa
CE/MDD
Care
Foshan Care Medical Technology Co., Ltd.
·
,
China
Class IIb
CE/MDD
Portable Medical Oxygen Concentrator
Shenyang RMS Medical Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Portable Oxygen Concentrator
Qingdao Kingon Medical Science and Technology Co., Ltd
·
,
China
Class IIa
CE/MDR
FI25/1008016
Active
Valid to Jun 2030
FDA 510(k)
K190304
Active
Cleared 29 Feb 2020
+1
authorizations
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
SimplyGo Mini, Standard Battery Kit
Respironics Inc.
·
,
United States
Class I
CE/MDR
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
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