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    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201128 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T06:09:56.663Z</lastUpdated>
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    <udiDi>05901292138028</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T06:07:11.339Z</lastUpdated>
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    <udiDi>04250203237925</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.9, überlang, L = 110 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>R0105010101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>201127 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T06:06:33.722Z</lastUpdated>
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    <udiDi>05901292138011</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-7019</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T06:03:31.039Z</lastUpdated>
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    <udiDi>04250203237895</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.8, überlang, L = 105 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201126 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T06:02:38.955Z</lastUpdated>
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  <row>
    <udiDi>05901292138004</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-7018</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:58:17.679Z</lastUpdated>
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  <row>
    <udiDi>04250203237864</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.7, überlang, L = 100 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201125 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:57:40.159Z</lastUpdated>
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    <udiDi>05901292137991</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-6555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:56:06.700Z</lastUpdated>
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  <row>
    <udiDi>04250203237833</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.6, überlang, L = 95 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201124 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:55:25.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292137984</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-6519</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:54:04.735Z</lastUpdated>
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  <row>
    <udiDi>04250203237802</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM®, Gr.5, überlang, L = 92 mm</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201123 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:53:27.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292137953</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-6055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:52:27.803Z</lastUpdated>
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  <row>
    <udiDi>04250203237680</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM® mit Uni-Aufsatz, Gr.12, 3-teilig</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200409 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:51:35.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292137946</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-6019</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:49:55.202Z</lastUpdated>
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  <row>
    <udiDi>04250203237659</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM® mit Uni-Aufsatz, Gr.11, 3-teilig</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200408 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:49:16.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901292137922</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-5555</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:48:07.704Z</lastUpdated>
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    <udiDi>04250203237628</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM® mit Uni-Aufsatz, Gr.10, 3-teilig</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200407 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:47:29.276Z</lastUpdated>
  </row>
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    <udiDi>05901292137915</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-5519</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:44:21.832Z</lastUpdated>
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  <row>
    <udiDi>04250203237598</udiDi>
    <basicUdiDi>42502032PRI06452</basicUdiDi>
    <tradeName>Trachealkanüle PRIMEDISTOM® mit Uni-Aufsatz, Gr.9, 3-teilig</tradeName>
    <deviceName>Primedistom</deviceName>
    <manufacturerName>Primed Halberstadt Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004967</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010101</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200406 u</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:43:32.057Z</lastUpdated>
  </row>
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    <udiDi>05901292137885</udiDi>
    <basicUdiDi>59012921RTBMQQ</basicUdiDi>
    <tradeName>Rurka tracheostomijna bez mankietu</tradeName>
    <deviceName>Rurka tracheostomijna bez mankietu</deviceName>
    <manufacturerName>SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa</manufacturerName>
    <manufacturerSrn>PL-MF-000010592</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0105010102</emdnCode>
    <emdnDescription>TRACHEOSTOMIC CANNUALS, CUFFLESS, NOT REINFORCED, WITH ADJUSTABLE FLANGE, AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>36-5055</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-07T05:42:07.807Z</lastUpdated>
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