15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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BYG INFORMATIQUE
FDA registration
BYG INFORMATIQUE·1 product·🇫🇷 France
Bag Monnal T60/T60 ADV
Device
EU MDR
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Eu Md Class 1
·Air Liquide Medical Systems S.A.·On the market·14 countries
Toda Coronadiag Ag - bag of 50
Device
EU IVDD
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Eu Ivd General
·TODA PHARMA·On the market
STARFIT ENTERAL DRAINAGE BAG SYSTEM 250ML
Device
EU MDR
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Eu Md Class 1
·HOIST MEDICAL ·On the market
STARFIT ENTERAL DRAINAGE BAG SYSTEM 100ML
Device
EU MDR
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Eu Md Class 1
·HOIST MEDICAL ·On the market
STARFIT ENTERAL DRAINAGE BAG SYSTEM 1000ML
Device
EU MDR
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Eu Md Class 1
·HOIST MEDICAL ·On the market
STARFIT ENTERAL DRAINAGE BAG SYSTEM 500ML
Device
EU MDR
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Eu Md Class 1
·HOIST MEDICAL ·On the market
Sac vomitoire à usage unique
Basic UDI-DI
EU MDR
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Eu Md Class 1
·MONDIALISTO·1 device
Sac vomitoire à usage unique
Basic UDI-DI
EU MDR
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Eu Md Class 1
·MONDIALISTO·1 device
BYO-TECH SAS
Authorized representative
🇫🇷 France·1 Manufacturer·11 Devices
Additional Waste Bag
Basic UDI-DI
EU MDR
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Eu Md Class 1
·i-SEP·4 devices
gΛt RePrint® storage bag
Basic UDI-DI
EU MDR
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Eu Md Class 1
·MaaT Pharma·1 device
Bag Monnal T60/T60 ADV
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Air Liquide Medical Systems S.A.·1 device
STARFIT ENTERAL DRAINAGE BAG SYSTEM
Basic UDI-DI
EU MDR
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Eu Md Class 1
·HOIST MEDICAL ·4 devices
Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, sterile, non pyrogenic solution for hypothermic flushing and storage of hearts. Celsior can be used for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the heart into the recipient. Celsior is packaged in one liter bag with 4 units per carton box. Celsior shall be stored between 36¿ to 46¿F. In Europe Celsior is a drug and can be used for thoracic organs (heart & lung) and abdominal organs (liver, kidney, pancreas).
FDA Enforcement
Class II
·Ongoing·INSTITUT GEORGES LOPEZ·August 6, 2025