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    <deviceName>StatSeal® Powder</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
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    <reference>LP636</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:47:37.605Z</lastUpdated>
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    <basicUdiDi>0834061005304QP</basicUdiDi>
    <tradeName>StatSeal (EN)</tradeName>
    <deviceName>StatSeal® Advanced RAD Disc</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAR630</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <udiDi>00834061005298</udiDi>
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    <tradeName>StatSeal (EN)</tradeName>
    <deviceName>StatSeal® Advanced Plus Disc</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAP629</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <tradeName>StatSeal (EN)</tradeName>
    <deviceName>StatSeal® Extra Large Disc</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DX627</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:47:20.768Z</lastUpdated>
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    <udiDi>00834061005250</udiDi>
    <basicUdiDi>0834061005250QR</basicUdiDi>
    <tradeName>StatSeal (EN)</tradeName>
    <deviceName>StatSeal® Medium Disc</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DM625</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:47:20.742Z</lastUpdated>
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    <udiDi>00834061005267</udiDi>
    <basicUdiDi>0834061005267RA</basicUdiDi>
    <tradeName>StatSeal (EN)</tradeName>
    <deviceName>StatSeal® Large Disc</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL626</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:47:20.736Z</lastUpdated>
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    <udiDi>00834061005243</udiDi>
    <basicUdiDi>0834061005243QU</basicUdiDi>
    <tradeName>StatSeal (EN)</tradeName>
    <deviceName>StatSeal® Small Disc</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS624</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:47:20.117Z</lastUpdated>
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    <udiDi>46972011720142</udiDi>
    <basicUdiDi>B-46972011720142</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002109</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECA2303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:50:41.562Z</lastUpdated>
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    <udiDi>46972011720135</udiDi>
    <basicUdiDi>B-46972011720135</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002109</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECA2302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:50:40.748Z</lastUpdated>
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    <udiDi>46972011720128</udiDi>
    <basicUdiDi>B-46972011720128</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002109</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EA230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:50:36.758Z</lastUpdated>
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    <udiDi>36972011720145</udiDi>
    <basicUdiDi>B-36972011720145</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002109</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECA2303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:48:20.431Z</lastUpdated>
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    <udiDi>36972011720138</udiDi>
    <basicUdiDi>B-36972011720138</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002109</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECA2302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:48:20.131Z</lastUpdated>
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    <udiDi>36972011720121</udiDi>
    <basicUdiDi>B-36972011720121</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002109</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EA230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:48:18.833Z</lastUpdated>
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    <udiDi>36972011720053</udiDi>
    <basicUdiDi>B-36972011720053</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Catheter</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002109</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPAA230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:48:14.835Z</lastUpdated>
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    <udiDi>36972011720046</udiDi>
    <basicUdiDi>B-36972011720046</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Catheter</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPAA180</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:48:14.283Z</lastUpdated>
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    <udiDi>26972011720148</udiDi>
    <basicUdiDi>B-26972011720148</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
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    <emdnCode>M040504</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECA2303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:11.386Z</lastUpdated>
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    <basicUdiDi>B-26972011720131</basicUdiDi>
    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
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    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECA2302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:10.586Z</lastUpdated>
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    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Adhesive</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
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    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EA230</reference>
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    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Catheter</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPAA230</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:05.781Z</lastUpdated>
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    <tradeName>EndoClot®</tradeName>
    <deviceName>EndoClot® Catheter</deviceName>
    <manufacturerName>EndoClot Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003672</manufacturerSrn>
    <authorisedRepresentativeName>ClotPlus Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EPAA180</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:14:04.985Z</lastUpdated>
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