14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Italy
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Hoestdrank 2-in-1 suikervrij 120 ml BE
Device
EU MDD
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Eu Md Class 2a
·Labomar S.p.A.·On the market·11 countries
SGABELLO PER VASCA DA BAGNO - 2 IN 1
Device
EU MDR
·
Eu Md Class 1
·PRAXIS MEDICAL NETWORK SRL·On the market
CVD000423
Certificate
MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'
CVD000523
Certificate
MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'
CSQ000823
Certificate
MDR QMS·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'
QCT-0066-17
Certificate
MDD Annex II (excluding section 4)·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·68 Basic UDI-DIs
EPG-0066-17
Certificate
MDD Annex II Section 4·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·28 Basic UDI-DIs
CVD 0004-23
Certificate
MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
CVD 0005-23
Certificate
MDR Technical Documentation·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
EPG-0065-17
Certificate
MDD Annex II Section 4·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·7 Basic UDI-DIs
EPG-0064-17
Certificate
MDD Annex II Section 4·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·34 Basic UDI-DIs
QCT-066-17
Certificate
MDD Annex II (excluding section 4)·Fin-ceramica faenza spa·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
EVOLUZIONE SOCIETA' A RESPONSABILITA' LIMITATA O IN BREVE EVOLUZIONE S.R.L.
System producer
🇮🇹 Italy
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2
FDA Enforcement
Class II
·Terminated·Sentinel CH SPA·August 9, 2017