24 results · 25ms · Sources: EU EUDAMED, US FDA

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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 · Eu Md Class 2a ·Medical Gas Criogenici Srl·On the market·1 country

Impianto di Evacuazione Gas Anestetici Sistema Venturi

Device
EU MDR · Eu Md Class 2a ·Medical Gas Criogenici Srl·On the market·1 country

BIOMAGNET

Device
EU MDD · Eu Md Class 2a ·NEW AGE ITALIA S.R.L.·On the market·32 countries

ENERPEEL GA-70

Basic UDI-DI
EU MDD · Eu Md Class 2b ·GENERAL TOPICS SRL·1 device

DHC

Basic UDI-DI
EU MDD · 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 · 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 · Eu Md Class 2a ·GENERAL TOPICS SRL·1 device

ENERPEEL GA-50

Basic UDI-DI
EU MDD · 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