15 results
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17ms
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Sources: EU EUDAMED, US FDA
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Country: France
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Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL)
FDA Enforcement
Class II
·Terminated·ELITech Clinical Systems SAS·November 11, 2015
Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL)
FDA Enforcement
Class II
·Terminated·ELITech Clinical Systems SAS·November 11, 2015
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT
FDA Enforcement
Class II
·Terminated·ELITech Clinical Systems SAS·November 11, 2015
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G
FDA Enforcement
Class II
·Terminated·ELITech Clinical Systems SAS·November 11, 2015
CDL SAS
Manufacturer
🇫🇷 France
XploreView Web
Device
EU MDR
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Eu Md Class 2a
·EDL (Edition et Développement de Logiciels)·On the market·1 country
XploreView
Device
EU MDR
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Eu Md Class 2a
·EDL (Edition et Développement de Logiciels)·On the market·1 country
RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Device
EU MDD
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Eu Md Class 2a
·EDL (Edition et Développement de Logiciels)·On the market·1 country
XploreView
Device
EU MDD
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Eu Md Class 2a
·EDL (Edition et Développement de Logiciels)·On the market·1 country
XploreView
Basic UDI-DI
EU MDR
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Eu Md Class 2a
·EDL (Edition et Développement de Logiciels)·2 devices
XploreView Web
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·EDL (Edition et Développement de Logiciels)·1 device
XploreView
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·EDL (Edition et Développement de Logiciels)·1 device
CE 663351
Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI
CE663351
Certificate
MDD Annex II (excluding section 4)·EDL (Edition et Développement de Logiciels)·BSI Group The Netherlands B.V.·1 Basic UDI-DI
HD 60144656
Certificate
MDD Annex II (excluding section 4)·Substrate HD·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI