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    <basicUdiDi>5024273HC108FF</basicUdiDi>
    <tradeName>ARCO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14HC811</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:35.157Z</lastUpdated>
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  <row>
    <udiDi>05024273149490</udiDi>
    <basicUdiDi>5024273N5NR</basicUdiDi>
    <tradeName>05024273149490</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0107 ARCO N5 S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:35.105Z</lastUpdated>
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  <row>
    <udiDi>05024273149506</udiDi>
    <basicUdiDi>5024273N5NR</basicUdiDi>
    <tradeName>05024273149506</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0108 ARCO N5 M</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:35.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024273149513</udiDi>
    <basicUdiDi>5024273N5NR</basicUdiDi>
    <tradeName>05024273149513</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0109 ARCO N5 L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:35.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024273149520</udiDi>
    <basicUdiDi>5024273N5NR</basicUdiDi>
    <tradeName>05024273149520</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0110 ARCO N5 XL</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:35.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024273149537</udiDi>
    <basicUdiDi>5024273N5NR</basicUdiDi>
    <tradeName>05024273149537</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0111 ARCO N5 XXL</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:35.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024273153367</udiDi>
    <basicUdiDi>5024273N4NP</basicUdiDi>
    <tradeName>05024273153367</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0203 N4 ARCO S</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:34.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024273153374</udiDi>
    <basicUdiDi>5024273N4NP</basicUdiDi>
    <tradeName>05024273153374</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0204 N4 ARCO M</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:34.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>05024273153381</udiDi>
    <basicUdiDi>5024273N4NP</basicUdiDi>
    <tradeName>05024273153381</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0205 N4 ARCO L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:34.958Z</lastUpdated>
  </row>
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    <udiDi>05024273153398</udiDi>
    <basicUdiDi>5024273N4NP</basicUdiDi>
    <tradeName>05024273153398</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCO Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000033950</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14J0206 N4 ARCO XL</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:31:34.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850331006000</udiDi>
    <basicUdiDi>0850331006SaeboStretchFE</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1-SS-10-SM-L-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.221Z</lastUpdated>
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  <row>
    <udiDi>00850331006017</udiDi>
    <basicUdiDi>0850331006SaeboStretchFE</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1-SS-10-MD-L-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.207Z</lastUpdated>
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  <row>
    <udiDi>00850331006024</udiDi>
    <basicUdiDi>0850331006SaeboStretchFE</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1-SS-10-LG-L-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.186Z</lastUpdated>
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    <udiDi>00850331006031</udiDi>
    <basicUdiDi>0850331006SaeboStretchFE</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1-SS-10-SM-R-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.173Z</lastUpdated>
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  <row>
    <udiDi>00850331006048</udiDi>
    <basicUdiDi>0850331006SaeboStretchFE</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1-SS-10-MD-R-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.161Z</lastUpdated>
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    <udiDi>00850331006055</udiDi>
    <basicUdiDi>0850331006SaeboStretchFE</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1-SS-10-LG-R-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.144Z</lastUpdated>
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    <udiDi>00850331006222</udiDi>
    <basicUdiDi>0850331006SaeboGloveX5</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1-GL-SM-XS-L-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.123Z</lastUpdated>
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    <udiDi>00850331006239</udiDi>
    <basicUdiDi>0850331006SaeboGloveX5</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1-GL-SM-SM-L-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.103Z</lastUpdated>
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  <row>
    <udiDi>00850331006246</udiDi>
    <basicUdiDi>0850331006SaeboGloveX5</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1-GL-MD-XS-L-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.072Z</lastUpdated>
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    <udiDi>00850331006253</udiDi>
    <basicUdiDi>0850331006SaeboGloveX5</basicUdiDi>
    <tradeName>Saebo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Saebo Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000052039</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>WRIST-HAND-FINGERS ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G1-GL-MD-SM-L-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:32:42.056Z</lastUpdated>
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