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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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Spirometry instruments
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Peak flow spirometers
Peak flow spirometers
Z12150102
81 devices
Spirolab Plus ESI
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
Spirobank II Light
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
Spirobank Smart
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
Peak Flow
Ningbo Greetmed Medical Instruments Co., Ltd.
·
,
China
Class I
CE/MDR
Cardboard Mouthpiece with One-Way Valve, Adult
Besmed Health Business Corp.
·
,
Taiwan
Class I
CE/MDR
Minispir Plus ESI
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
AM3
eResearchTechnology GmbH
·
,
Germany
Class IIa
CE/MDR
GUDID
on market
lifesense
Taian Dalu Medical Instrument Co., Ltd.
·
,
China
Class I
CE/MDR
Spirolab Plus
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
Spirobank II Plus
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
Durable Mouthpiece with One-Way Valve, Adult
Besmed Health Business Corp.
·
,
Taiwan
Class I
CE/MDR
Peak Flow Meter
Shanghai Everpure Medical Plastic Co., Ltd.
·
,
China
Class I
CE/MDR
Spirobank II Plus
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
Peak flow meter-standard range 50-800 L/min
Besmed Health Business Corp.
·
,
Taiwan
Class I
FDA 510(k)
K172804
Active
Cleared 11 Jan 2018
CE/MDR
+1
authorizations
Spirolab Plus ESI
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
Spirobank II Plus
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
Karaoğlu
Karaoğlu Baskül Ve Cerrahi̇ Aletler İmal. San. Ti̇c. Ltd. Şti̇
·
,
Türkiye
Class I
CE/MDR
Peak Flow Meter
Suzhou Tedamed Co., Ltd
·
,
China
Class I
CE/MDR
Spirobank II Plus
Mir Medical International Research SpA
·
,
Italy
Class IIa
CE/MDR
GUDID
on market
Microlife
ShenZhen Bi-rich Medical Devices Co., Ltd
·
,
China
Class I
CE/MDR
CN25/00003166
Active
Valid to May 2030
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