24 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Italy
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AGEING TECH SRL
Manufacturer
🇮🇹 Italy·1 Basic UDI-DI·1 Device·BUREAU VERITAS ITALIA S.P.A.
Age Solutions Srl
Manufacturer
🇮🇹 Italy·TUV Rheinland Italia SRL
NEW AGE ITALIA S.R.L.
Manufacturer
🇮🇹 Italy·1 Basic UDI-DI·1 Device·MTIC InterCert S.r.l.
DHC
Device
EU MDD
·
Eu Md Class 2a
·AGEING TECH SRL·On the market·32 countries
Impianto di Evacuazione Gas Anestetici Sistema a Soffianti
Device
EU MDR
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Eu Md Class 2a
·Medical Gas Criogenici Srl·On the market·1 country
Impianto di Evacuazione Gas Anestetici Sistema Venturi
Device
EU MDR
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Eu Md Class 2a
·Medical Gas Criogenici Srl·On the market·1 country
BIOMAGNET
Device
EU MDD
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Eu Md Class 2a
·NEW AGE ITALIA S.R.L.·On the market·32 countries
ENERPEEL GA-70
Basic UDI-DI
EU MDD
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Eu Md Class 2b
·GENERAL TOPICS SRL·1 device
DHC
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·AGEING TECH SRL·1 device
IT305000
Certificate
MDD Annex II (excluding section 4)·AGEING TECH SRL·BUREAU VERITAS ITALIA S.P.A.·1 Basic UDI-DI
ITH 2379777 1
Certificate
MDR QMS·Age Solutions Srl·TUV Rheinland Italia SRL
Impianti Evacuazione Gas Anestetici
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·Medical Gas Criogenici Srl·2 devices
BIOMAGNET
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·NEW AGE ITALIA S.R.L.·1 device
051-00-00-MDR
Certificate
MDR QMS·Medical Gas Criogenici Srl·ITALCERT SRL
0068/QPR-DM/179-2020
Certificate
MDD Annex VI·NEW AGE ITALIA S.R.L.·MTIC InterCert S.r.l.·1 Basic UDI-DI
Tecno-Gaz S.p.A
System producer
🇮🇹 Italy
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Enforcement
Class II
·Ongoing·EMPATICA SRL·November 1, 2023
ENERPEEL GA-70
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·GENERAL TOPICS SRL·1 device
ENERPEEL GA-50
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·GENERAL TOPICS SRL·1 device
ENERPEEL GA-40
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·GENERAL TOPICS SRL·1 device