9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Country: France
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Argon Medicale per criochirurgia 300 bar B50
Device
EU MDR
·
Eu Md Class 1
·Messer France·On the market
Senographe Pristina
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, SCS·February 14, 2024
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
FIXA-PED-NI
Basic UDI-DI
EU MDR
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Eu Md Class 1
·ACIME FRAME·2 devices
SKOT-PED-NI
Basic UDI-DI
EU MDR
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Eu Md Class 1
·ACIME FRAME·1 device
IT267632 - 1
Certificate
MDD Annex II (excluding section 4)·DIS PAR·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI
10217
Certificate
MDD Annex VI·Laboratoire de la Mer·GMED SAS·1 Basic UDI-DI
10218
Certificate
MDD Annex V·Laboratoire de la Mer·GMED SAS·4 Basic UDI-DIs
10214
Certificate
MDD Annex V·Laboratoire de la Mer·GMED SAS·1 Basic UDI-DI