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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
Medical oxygen concentrator
Longfian Scitech Co., Ltd.
·
,
China
Class IIa
CE/MDR
CE/MDD
Go Top Line Health 6 D1000
GasN2Itrogen S.L.
·
,
Spain
Class IIb
CE/MDR
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
Medical Air/Oxygen Blender
Ningbo David Medical Device Co., Ltd.
·
,
China
Class IIb
CE/MDR
CE/MDD
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
Bottle 9000
Photon 4 Health B.V.
·
,
Netherlands
Class I
CE/MDR
Go Top Line Health 15 D1000
GasN2Itrogen S.L.
·
,
Spain
Class IIb
CE/MDR
Hikoneb Oxybreath Mini 5
KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi.
·
,
Türkiye
Class IIb
CE/MDD
Sümer
Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
·
,
Türkiye
Class IIb
CE/MDD
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
JLO-190P, Galena
Shenzhen Homed Medical Device Co., Ltd.
·
,
China
Class IIb
CE/MDR
Medical Oxygen Concentrator
Shenyang Aerti Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
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)
K251764
Active
Cleared 22 Dec 2025
+1
authorizations
Portable Medical Oxygen Concentrator
Shenyang RMS Medical Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Mark 5 Nuvo 8
Nidek Medical Products Inc.
·
,
United States
Class IIb
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
GUDID
on market
Medical Oxygen Concentrator
Shenyang Aerti Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
Mark 5 Nuvo Lite
Nidek Medical Products Inc.
·
,
United States
Class IIa
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
FDA 510(k)
K123738
Active
Cleared 28 Feb 2013
+2
authorizations
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