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

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Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T

FDA Enforcement
Class II ·Ongoing·BD SWITZERLAND SARL·June 18, 2025

Swissdentacare SA

Manufacturer
🇨🇭 Switzerland·1 Importer

Mono Fixture Regular Smooth-Large Abutment

Device
EU MDD · Eu Md Class 2b ·Novodent SA·On the market·1 country

CEROTTO PROFUMATO PER INCONTINENZA E STOMA

Device
EU MDR · Eu Md Class 1 ·Air Note GmbH·On the market

CEROTTO PROFUMATO PER INCONTINENZA E STOMA

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Air Note GmbH·1 device

V1 092658 0004

Certificate
IVDD Annex IV (excluding sections 4, 6)·ForaCare Suisse AG·TÜV SÜD Product Service GmbH·9 Basic UDI-DIs

G1 092658 0006

Certificate
MDD Annex II (excluding section 4)·ForaCare Suisse AG·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs

G1 092658 0006

Certificate
MDD Annex II (excluding section 4)·ForaCare Suisse AG·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

V1 092658 0004

Certificate
IVDD Annex IV (excluding sections 4, 6)·ForaCare Suisse AG·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

V1 092658 0004 Rev. 06

Certificate
IVDD Annex IV (excluding sections 4, 6)·ForaCare Suisse AG·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

HD 60138182 0001

Certificate
MDD Annex II (excluding section 4)·Biodenta Swiss AG·TÜV Rheinland LGA Products GmbH·5 Basic UDI-DIs