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    <tradeName>08800012335006</tradeName>
    <deviceName>Fetal monitor</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:39.955Z</lastUpdated>
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    <udiDi>08800012330018</udiDi>
    <basicUdiDi>B-08800012330018</basicUdiDi>
    <tradeName>08800012330018</tradeName>
    <deviceName>Fetal monitor</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Biocare FM-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:39.146Z</lastUpdated>
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    <udiDi>08800012330001</udiDi>
    <basicUdiDi>B-08800012330001</basicUdiDi>
    <tradeName>08800012330001</tradeName>
    <deviceName>Fetal monitor</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:37.808Z</lastUpdated>
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    <udiDi>05051968019172</udiDi>
    <basicUdiDi>5060693520358WM</basicUdiDi>
    <tradeName>SONICAID</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD1-P-EUR</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:44.013Z</lastUpdated>
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    <udiDi>05051968030047</udiDi>
    <basicUdiDi>5060693520358WM</basicUdiDi>
    <tradeName>SONICAID</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D930-P</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:43.382Z</lastUpdated>
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    <udiDi>05051968030054</udiDi>
    <basicUdiDi>5060693520358WM</basicUdiDi>
    <tradeName>SONICAID</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD3-P</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T23:56:43.275Z</lastUpdated>
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    <udiDi>07045432092301</udiDi>
    <basicUdiDi>B-07045432092301</basicUdiDi>
    <tradeName>Moyo - Fetal Heart Rate Monito</tradeName>
    <deviceName>Moyo</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LGH-510-00033</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:02.067Z</lastUpdated>
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  <row>
    <udiDi>07045432063820</udiDi>
    <basicUdiDi>B-07045432063820</basicUdiDi>
    <tradeName>Moyo - Fetal Heart Rate Monitor</tradeName>
    <deviceName>Moyo</deviceName>
    <manufacturerName>Laerdal Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000012</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510-00033</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:54:11.072Z</lastUpdated>
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    <udiDi>00884838000438</udiDi>
    <basicUdiDi>B-00884838000438</basicUdiDi>
    <tradeName>Avalon FM50 Fetal Monitor</tradeName>
    <deviceName>FM20-50</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>865071</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:00:02.267Z</lastUpdated>
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    <udiDi>00884838000421</udiDi>
    <basicUdiDi>B-00884838000421</basicUdiDi>
    <tradeName>Avalon FM40 Fetal Monitor</tradeName>
    <deviceName>FM20-50</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>865132</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:00:00.666Z</lastUpdated>
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    <udiDi>00884838000414</udiDi>
    <basicUdiDi>B-00884838000414</basicUdiDi>
    <tradeName>Avalon FM30 Fetal Monitor</tradeName>
    <deviceName>FM20-50</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>862199</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:59.868Z</lastUpdated>
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  <row>
    <udiDi>00884838000407</udiDi>
    <basicUdiDi>B-00884838000407</basicUdiDi>
    <tradeName>Avalon FM20 Fetal Monitor</tradeName>
    <deviceName>FM20-50</deviceName>
    <manufacturerName>Philips Medizin Systeme Böblingen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>862198</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:58.269Z</lastUpdated>
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  <row>
    <udiDi>06934667961357</udiDi>
    <basicUdiDi>69346679SRF1001ZT</basicUdiDi>
    <tradeName>SRF618B6</tradeName>
    <deviceName>Fetal Monitor</deviceName>
    <manufacturerName>Guangzhou Sunray Medical Apparatus Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019807</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>069346679</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:58:53.882Z</lastUpdated>
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  <row>
    <udiDi>05051968032485</udiDi>
    <basicUdiDi>5060693520389WY</basicUdiDi>
    <tradeName>SONICAID</tradeName>
    <deviceName>ANTEPARTUM/PRINTER</deviceName>
    <manufacturerName>ArjoHuntleigh AB</manufacturerName>
    <manufacturerSrn>SE-MF-000000696</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TEAM3A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:28:33.986Z</lastUpdated>
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  <row>
    <udiDi>06970706360637</udiDi>
    <basicUdiDi>B-06970706360637</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SL03</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:21:06.382Z</lastUpdated>
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    <udiDi>06970706360620</udiDi>
    <basicUdiDi>B-06970706360620</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SL02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:21:05.184Z</lastUpdated>
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    <udiDi>06970706360613</udiDi>
    <basicUdiDi>B-06970706360613</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SL01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:59.179Z</lastUpdated>
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    <udiDi>06970706360606</udiDi>
    <basicUdiDi>B-06970706360606</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SC02</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:57.976Z</lastUpdated>
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    <udiDi>06970706360583</udiDi>
    <basicUdiDi>B-06970706360583</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-SC01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:56.773Z</lastUpdated>
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  <row>
    <udiDi>06970706360576</udiDi>
    <basicUdiDi>B-06970706360576</basicUdiDi>
    <tradeName>TOCO Fetal transducer</tradeName>
    <deviceName>TOCO Fetal transducer</deviceName>
    <manufacturerName>Orantech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000013859</manufacturerSrn>
    <authorisedRepresentativeName>Medten EU ApS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DK-AR-000034434</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTC-AL01</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-30T05:20:55.578Z</lastUpdated>
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