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    <tradeName>CT Sanofi LPS15497 Software Pkg Site</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1143211</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:12.184Z</lastUpdated>
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    <udiDi>00606959419797</udiDi>
    <basicUdiDi>B-00606959419797</basicUdiDi>
    <tradeName>CT Sanofi LPS15497 Software Pkg Scorer-6</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1143210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:11.378Z</lastUpdated>
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    <udiDi>00606959418998</udiDi>
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    <tradeName>AW CT Regeneron R3500-AD-1798 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1140958</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:04.971Z</lastUpdated>
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    <udiDi>00606959418882</udiDi>
    <basicUdiDi>B-00606959418882</basicUdiDi>
    <tradeName>AW CT Angelini 152PO17433 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1140687</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:04.183Z</lastUpdated>
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  <row>
    <udiDi>00606959418769</udiDi>
    <basicUdiDi>B-00606959418769</basicUdiDi>
    <tradeName>AW CT Ovid OV101-17-002 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1140325</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:03.378Z</lastUpdated>
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  <row>
    <udiDi>00606959418103</udiDi>
    <basicUdiDi>B-00606959418103</basicUdiDi>
    <tradeName>AW CT Janssen 42756493BLC3001 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1139805</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:16:02.574Z</lastUpdated>
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    <udiDi>00606959417526</udiDi>
    <basicUdiDi>B-00606959417526</basicUdiDi>
    <tradeName>AW CT Ovid OV101-17-001 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1138806</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:57.782Z</lastUpdated>
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  <row>
    <udiDi>00606959416741</udiDi>
    <basicUdiDi>B-00606959416741</basicUdiDi>
    <tradeName>AW CT Janssen CNTO1275CRD3007 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1137889</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:56.968Z</lastUpdated>
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    <udiDi>00606959416536</udiDi>
    <basicUdiDi>B-00606959416536</basicUdiDi>
    <tradeName>AW CT Novartis CAIN457FUS06 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1137568</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:56.289Z</lastUpdated>
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    <udiDi>00606959416413</udiDi>
    <basicUdiDi>B-00606959416413</basicUdiDi>
    <tradeName>AW CT MT-8554-E06 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1135751</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:51.361Z</lastUpdated>
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  <row>
    <udiDi>00606959415973</udiDi>
    <basicUdiDi>B-00606959415973</basicUdiDi>
    <tradeName>AW CT Kiniksa KPL-OBS001 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1135139</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:50.561Z</lastUpdated>
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    <udiDi>00606959415553</udiDi>
    <basicUdiDi>B-00606959415553</basicUdiDi>
    <tradeName>AW CT Kiniksa KPL-716-C001  Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1134316</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:49.758Z</lastUpdated>
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  <row>
    <udiDi>00606959413795</udiDi>
    <basicUdiDi>B-00606959413795</basicUdiDi>
    <tradeName>AW CT Janssen NOPRODBIP0001 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1131704</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:44.961Z</lastUpdated>
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    <udiDi>00606959414426</udiDi>
    <basicUdiDi>B-00606959414426</basicUdiDi>
    <tradeName>Novartis Software PkgScorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1132329</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:43.352Z</lastUpdated>
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    <udiDi>00606959414051</udiDi>
    <basicUdiDi>B-00606959414051</basicUdiDi>
    <tradeName>AW CT Roche BP29937 Pkg Scorer</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1131667</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:42.564Z</lastUpdated>
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    <udiDi>00606959409842</udiDi>
    <basicUdiDi>B-00606959409842</basicUdiDi>
    <tradeName>Actiwatch Spectrum Plus-Recertified</tradeName>
    <deviceName>Actiwatch Spectrum Pro and Actiwatch Spe</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1101894</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:09.669Z</lastUpdated>
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    <udiDi>00606959409835</udiDi>
    <basicUdiDi>B-00606959409835</basicUdiDi>
    <tradeName>Actiwatch Spectrum PRO-Recertified</tradeName>
    <deviceName>Actiwatch Spectrum Pro and Actiwatch Spe</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U1099351</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:15:08.877Z</lastUpdated>
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    <udiDi>00606959409675</udiDi>
    <basicUdiDi>B-00606959409675</basicUdiDi>
    <tradeName>Actiwatch Spectrum Plus-Rental</tradeName>
    <deviceName>Actiwatch Spectrum Pro and Actiwatch Spe</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1101894</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:57.663Z</lastUpdated>
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    <udiDi>00606959409668</udiDi>
    <basicUdiDi>B-00606959409668</basicUdiDi>
    <tradeName>Actiwatch Spectrum PRO-Rental</tradeName>
    <deviceName>Actiwatch Spectrum Pro and Actiwatch Spe</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>R1099351</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:14:56.863Z</lastUpdated>
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    <udiDi>00606959040366</udiDi>
    <basicUdiDi>B-00606959040366</basicUdiDi>
    <tradeName>Actiware Clinical Trial Software, English - 6</tradeName>
    <deviceName>Actiware Software, Actiware CT Software</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040117</emdnCode>
    <emdnDescription>METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1103609</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:08:47.504Z</lastUpdated>
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