51 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Taiwan
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Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
FDA Enforcement
Class II
·Terminated·EMG Technology Co., Ltd.·September 24, 2014
Medical Bed
Device
EU MDR
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Eu Md Class 1
·Enigma Care Co., Ltd.·On the market·2 countries
Treatment Table
Device
EU MDR
·
Eu Md Class 1
·Enigma Care Co., Ltd.·On the market
Canpol babies Baby Nasal Aspirator
Device
EU MDR
·
Eu Md Class 1
·Acute Ideas Co., Ltd.·On the market
ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED
Device
EU MDD
·
Eu Md Class 2a
·Omnimate Enterprise Co., Ltd.·On the market·1 country
NASOPHARYNGEAL TUBES
Device
EU MDD
·
Eu Md Class 2a
·Omnimate Enterprise Co., Ltd.·On the market·1 country
MANUALLY OPERATED PULMONARY RESUSCITATORS
Device
EU MDD
·
Eu Md Class 2a
·Omnimate Enterprise Co., Ltd.·On the market·1 country
Canpol babies Baby Nasal Aspirator
Device
EU MDR
·
Eu Md Class 1
·Acute Ideas Co., Ltd.·On the market
Rooti Rx
Device
EU MDR
·
Eu Md Class 2a
·Rooti Labs Limited.·On the market·2 countries
RootiCare System
Device
EU MDR
·
Eu Md Class 2a
·Rooti Labs Limited.·On the market·2 countries
Medical Bed
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Enigma Care Co., Ltd.·1 device
Manual Nasal Aspirator
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Acute Ideas Co., Ltd.·2 devices
Single Patient Use Manual Resuscitator Unit
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Omnimate Enterprise Co., Ltd.·1 device
Treatment Table
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Enigma Care Co., Ltd.·1 device
Endotracheal Tube
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Omnimate Enterprise Co., Ltd.·1 device
Nasopharyngeal Airway
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·Omnimate Enterprise Co., Ltd.·1 device
TW24/00000579
Certificate
MDR QMS·Yung Sheng Optical Co., Ltd.·SGS Belgium NV
2195-MED-2113202
Certificate
MDD Annex II Section 4·Omnimate Enterprise Co., Ltd.·Szutest Uygunluk Değerlendirme A.Ş.·3 Basic UDI-DIs
Rooti Rx System
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Rooti Labs Limited.·2 devices
Lagis Enterprise Co., Ltd.
System producer
🇹🇼 Taiwan