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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
Nuvo Nano
Nidek Medical Products Inc.
·
,
United States
Class IIa
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
CE/MDD
+1
authorizations
Sümer
Sümer Uluslararasi Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
·
,
Türkiye
Class IIb
CE/MDD
Max 30
Nidek Medical Products Inc.
·
,
United States
Class IIb
CE/MDR
28620155820-00-01
Active
Valid to Dec 2027
Medical Oxygen Concentrator
Shenyang Aerti Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Portable Medical Oxygen Concentrator
Shenyang RMS Medical Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Oxyworld
Medi̇sam İnşaat Sağlik Si̇stemleri̇ Li̇mi̇ted Şi̇rketi̇ Kahramankazan Şubesi̇
·
,
Türkiye
Class IIb
CE/MDD
Oxygen Concentrator
Oxytek Medical Technology Co., Ltd
·
,
China
Class IIb
CE/MDR
Portable Oxygen Concentrator
Bmc Medical., Ltd.
·
,
China
Class IIb
CE/MDR
Prizma O2
Prizma Kragujevac Doo
·
,
Serbia
Class IIb
CE/MDR
Portable Medical Oxygen Concentrator
Shenyang RMS Medical Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Oxygen Concentrator
Famidoc Technology Company Limited
·
,
China
Class IIa
CE/MDR
Manual hospital bed and accessories
Jianlian Homecare Products Co., Ltd
·
,
China
Class I
CE/MDR
Medical Oxygen Concentrator
Shenyang Aerti Tech Co., Ltd.
·
,
China
Class IIb
CE/MDR
Freestyle Comfort
Caire Inc.
·
,
United States
Class IIa
FDA 510(k)
K250671
Active
Cleared 11 Jul 2025
CE/MDD
SimplyGo, Battery (Extra/Replacement)
Respironics Inc.
·
,
United States
Class I
CE/MDR
Oxygen Concentrator
Elmaslar İmalat Tibbi̇ Ci̇hazlar İnş. Taş.i̇th.i̇hr.san. Ve Ti̇c.a.ş.
·
,
Türkiye
Class IIa
CE/MDD
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
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
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