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    <deviceName>952-0032</deviceName>
    <manufacturerName>Oy Fluorplast Ab</manufacturerName>
    <manufacturerSrn>FI-MF-000015708</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>COLORECTAL INSUFFLATION TUBES</emdnDescription>
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    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:57:02.247Z</lastUpdated>
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    <udiDi>06418879142310</udiDi>
    <basicUdiDi>B-06418879142310</basicUdiDi>
    <tradeName>YA Makrogoli suolaton 20x12g</tradeName>
    <deviceName>YA Makrogoli suolaton</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>9919841</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:51:20.465Z</lastUpdated>
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    <udiDi>06418879125306</udiDi>
    <basicUdiDi>B-06418879125306</basicUdiDi>
    <tradeName>YA Makrogoli suolaton 50x12g</tradeName>
    <deviceName>YA Makrogoli suolaton</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>9918361</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:51:16.451Z</lastUpdated>
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    <basicUdiDi>B-06418879107302</basicUdiDi>
    <tradeName>YA Makrogoli 50x13,7g</tradeName>
    <deviceName>YA Makrogoli</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9916501</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:51:14.857Z</lastUpdated>
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    <udiDi>06418879101096</udiDi>
    <basicUdiDi>B-06418879101096</basicUdiDi>
    <tradeName>YA Makrogoli 750g</tradeName>
    <deviceName>YA Makrogoli</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9912811</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:51:14.073Z</lastUpdated>
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    <udiDi>06418879100730</udiDi>
    <basicUdiDi>B-06418879100730</basicUdiDi>
    <tradeName>YA Makrogoli 10x13,7g</tradeName>
    <deviceName>YA Makrogoli</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9911997</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:51:08.452Z</lastUpdated>
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    <udiDi>06417952243869</udiDi>
    <basicUdiDi>B-06417952243869</basicUdiDi>
    <tradeName>LaktasDUO 80 kapslar</tradeName>
    <deviceName>LaktasDUO 80 kapslar</deviceName>
    <manufacturerName>Pharmia Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001469</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LADD04</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:49:14.692Z</lastUpdated>
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    <udiDi>06417952243852</udiDi>
    <basicUdiDi>B-06417952243852</basicUdiDi>
    <tradeName>LaktasDUO 30 kapslar</tradeName>
    <deviceName>LaktasDUO 30 kapslar</deviceName>
    <manufacturerName>Pharmia Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001469</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LADD02</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:49:13.085Z</lastUpdated>
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    <udiDi>06417952243845</udiDi>
    <basicUdiDi>B-06417952243845</basicUdiDi>
    <tradeName>APTEEKKI Tehokapseli Duo, kapseli, 30 kpl</tradeName>
    <deviceName>APTEEKKI Tehokapseli Duo, kapseli, 30 kpl</deviceName>
    <manufacturerName>Pharmia Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001469</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LMED04.1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:49:10.692Z</lastUpdated>
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    <udiDi>06417952243838</udiDi>
    <basicUdiDi>B-06417952243838</basicUdiDi>
    <tradeName>APTEEKKI Tehokapseli Duo, kapseli, 10 kpl</tradeName>
    <deviceName>APTEEKKI Tehokapseli Duo, kapseli,10 kpl</deviceName>
    <manufacturerName>Pharmia Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001469</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>LMED04</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:49:09.071Z</lastUpdated>
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    <udiDi>06417927103426</udiDi>
    <basicUdiDi>B-06417927103426</basicUdiDi>
    <tradeName>Smartlax peräruiske 50x5ml</tradeName>
    <deviceName>Smartlax peräruiske</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G99</emdnCode>
    <emdnDescription>GASTROINTESTINAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2150308</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:12.990Z</lastUpdated>
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    <udiDi>06417927103402</udiDi>
    <basicUdiDi>B-06417927103402</basicUdiDi>
    <tradeName>Smartlax peräruiske 12x5ml</tradeName>
    <deviceName>Smartlax peräruiske</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G99</emdnCode>
    <emdnDescription>GASTROINTESTINAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2150159</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:11.381Z</lastUpdated>
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    <udiDi>06417927103389</udiDi>
    <basicUdiDi>B-06417927103389</basicUdiDi>
    <tradeName>Smartlax peräruiske 4x5ml</tradeName>
    <deviceName>Smartlax peräruiske</deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G99</emdnCode>
    <emdnDescription>GASTROINTESTINAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2150001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:08.994Z</lastUpdated>
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    <udiDi>06941112303914</udiDi>
    <basicUdiDi>69411123L23TJ</basicUdiDi>
    <tradeName>06941112303914</tradeName>
    <deviceName>Single-use Biliary Drainage Catheter</deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040301</emdnCode>
    <emdnDescription>BILIARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L23D07005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:58:53.445Z</lastUpdated>
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    <udiDi>06941112303938</udiDi>
    <basicUdiDi>69411123L23TJ</basicUdiDi>
    <tradeName>06941112303938</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040301</emdnCode>
    <emdnDescription>BILIARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L23D07007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:58:53.412Z</lastUpdated>
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    <tradeName>06941112303969</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>G03040301</emdnCode>
    <emdnDescription>BILIARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L23D07010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:58:53.338Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040301</emdnCode>
    <emdnDescription>BILIARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L23D07012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:58:53.293Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040301</emdnCode>
    <emdnDescription>BILIARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L23D07015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:58:53.249Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040301</emdnCode>
    <emdnDescription>BILIARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L23D08503</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:58:53.218Z</lastUpdated>
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    <tradeName>06941112304270</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040301</emdnCode>
    <emdnDescription>BILIARY TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L23D10005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:58:53.174Z</lastUpdated>
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