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    <tradeName>Neonatal Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B6A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:23.242Z</lastUpdated>
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    <udiDi>06945429090024</udiDi>
    <basicUdiDi>69454290NI003MU</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>06945429090031</udiDi>
    <basicUdiDi>69454290NI003MU</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:22.858Z</lastUpdated>
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    <udiDi>06945429090048</udiDi>
    <basicUdiDi>69454290NI003MU</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B3A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:22.633Z</lastUpdated>
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    <udiDi>D-869931091VAVX9</udiDi>
    <basicUdiDi>B-869931091VAVX9</basicUdiDi>
    <tradeName>Tende Elektronik Yazılım Mühendislik İletişim Makina Sanayi Ve Ticaret Ltd. Şti.</tradeName>
    <deviceName>VAV YOĞUN BAKIM BEBEK KUVÖZÜ</deviceName>
    <manufacturerName>Tende Elektronik Yazılım Mühendislik İletişim Makine Sanayi Ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000019054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAV</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:03:06.182Z</lastUpdated>
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    <udiDi>D-869931091VAV-TRUS</udiDi>
    <basicUdiDi>B-869931091VAV-TRUS</basicUdiDi>
    <tradeName>Tende Elektronik Yazılım Mühendislik İletişim Makina Sanayi Ve Ticaret Ltd. Şti.</tradeName>
    <deviceName>VAV-TR YOĞUN BAKIM TRANSPORT (Taşınabilir) BEBEK KUVÖZÜ</deviceName>
    <manufacturerName>Tende Elektronik Yazılım Mühendislik İletişim Makine Sanayi Ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000019054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAV-TR</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:03:05.383Z</lastUpdated>
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    <udiDi>D-869931091VAV-IWU3</udiDi>
    <basicUdiDi>B-869931091VAV-IWU3</basicUdiDi>
    <tradeName>Tende Elektronik Yazılım Mühendislik İletişim Makina Sanayi Ve Ticaret Ltd. Şti.</tradeName>
    <deviceName>BEBEK RADYANT ISITICI</deviceName>
    <manufacturerName>Tende Elektronik Yazılım Mühendislik İletişim Makine Sanayi Ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000019054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VAV-IW</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:03:04.589Z</lastUpdated>
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    <udiDi>D-869931091PT5J</udiDi>
    <basicUdiDi>B-869931091PT5J</basicUdiDi>
    <tradeName>CAREBLUE</tradeName>
    <deviceName>Led Phototherapy Device</deviceName>
    <manufacturerName>Tende Elektronik Yazılım Mühendislik İletişim Makine Sanayi Ve Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000019054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAREBLUE</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:03:00.586Z</lastUpdated>
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    <udiDi>08908003989013</udiDi>
    <basicUdiDi>08908003989SapphireZE</basicUdiDi>
    <tradeName>Seefar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 4000 SPOT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:17:33.284Z</lastUpdated>
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    <udiDi>08908003989259</udiDi>
    <basicUdiDi>08908003989Operah7Z</basicUdiDi>
    <tradeName>Operah</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 2010 BC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:17:32.876Z</lastUpdated>
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    <udiDi>08908003989273</udiDi>
    <basicUdiDi>08908003989Operah7Z</basicUdiDi>
    <tradeName>Operah</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 2010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:17:32.792Z</lastUpdated>
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    <udiDi>06945429021127</udiDi>
    <basicUdiDi>69454290BQ002KE</basicUdiDi>
    <tradeName>06945429021127</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQ80A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:11:16.380Z</lastUpdated>
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    <udiDi>D-3600AJ</udiDi>
    <basicUdiDi>B-3600AJ</basicUdiDi>
    <tradeName>SATIS +</tradeName>
    <deviceName>SATIS +</deviceName>
    <manufacturerName>MEDIPREMA</manufacturerName>
    <manufacturerSrn>FR-MF-000011274</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:37:31.368Z</lastUpdated>
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    <udiDi>08908003989266</udiDi>
    <basicUdiDi>B-08908003989266</basicUdiDi>
    <tradeName>Operah</tradeName>
    <deviceName>Infant Radiant Warmer</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 2010 B</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:14.422Z</lastUpdated>
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    <udiDi>08908003989105</udiDi>
    <basicUdiDi>B-08908003989105</basicUdiDi>
    <tradeName>Wallaby</tradeName>
    <deviceName>Infant Incubator</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 3010 H</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:12.839Z</lastUpdated>
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    <udiDi>08908003989099</udiDi>
    <basicUdiDi>B-08908003989099</basicUdiDi>
    <tradeName>Operah</tradeName>
    <deviceName>Infant Radiant Warmer</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:12.053Z</lastUpdated>
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    <udiDi>08908003989082</udiDi>
    <basicUdiDi>B-08908003989082</basicUdiDi>
    <tradeName>Operah Plus</tradeName>
    <deviceName>Infant Radiant Warmer with Phototherapy</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 5000 P</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:26:09.622Z</lastUpdated>
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    <udiDi>08906033940301</udiDi>
    <basicUdiDi>B-08906033940301</basicUdiDi>
    <tradeName>08906033940301</tradeName>
    <deviceName>Infant Phototherapy Unit</deviceName>
    <manufacturerName>Phoenix Medical Systems Pvt. Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000022931</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.2.3‐47</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:54:58.676Z</lastUpdated>
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    <udiDi>08906033940288</udiDi>
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    <tradeName>08906033940288</tradeName>
    <deviceName>Infant Phototherapy Unit</deviceName>
    <manufacturerName>Phoenix Medical Systems Pvt. Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000022931</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.2.3‐30B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:54:53.155Z</lastUpdated>
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    <udiDi>08906033940257</udiDi>
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    <tradeName>08906033940257</tradeName>
    <deviceName>Infant Radiant Warmer</deviceName>
    <manufacturerName>Phoenix Medical Systems Pvt. Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000022931</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080407</emdnCode>
    <emdnDescription>NEONATAL RADIANT WARMERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.2.3‐11A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:54:52.355Z</lastUpdated>
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