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    <tradeName>Ekal Surgical Works</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ekal	Surgical Works</manufacturerName>
    <manufacturerSrn>PK-MF-000015524</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79-100-10P</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:57:27.892Z</lastUpdated>
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    <udiDi>08961102786907</udiDi>
    <basicUdiDi>896110278DRMS808QC</basicUdiDi>
    <tradeName>Dermatoscope Set, SIGMA 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medical Devices (Pvt) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000021845</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808-550-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T18:57:16.780Z</lastUpdated>
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    <udiDi>08961102786914</udiDi>
    <basicUdiDi>896110278DRMS808QC</basicUdiDi>
    <tradeName>Dermatoscope Set, Omni 3000, 2.5V Xenon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medical Devices (Pvt) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000021845</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808-560-25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T18:57:16.747Z</lastUpdated>
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    <udiDi>08961102786921</udiDi>
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    <tradeName>Dermatoscope Head, SIGMA 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medical Devices (Pvt) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000021845</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808-550-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T18:57:16.686Z</lastUpdated>
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    <udiDi>08961102786938</udiDi>
    <basicUdiDi>896110278DRMS808QC</basicUdiDi>
    <tradeName>Dermatoscope Head, Omni 3000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medical Devices (Pvt) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000021845</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808-560-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T18:57:16.646Z</lastUpdated>
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    <udiDi>08961102786945</udiDi>
    <basicUdiDi>896110278DRMS808QC</basicUdiDi>
    <tradeName>Contact Plate with Scale, SIGMA 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medical Devices (Pvt) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000021845</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808-550-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T18:57:16.612Z</lastUpdated>
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    <udiDi>08961102786952</udiDi>
    <basicUdiDi>896110278DRMS808QC</basicUdiDi>
    <tradeName>Contact Plate Plain, SIGMA 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medical Devices (Pvt) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000021845</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808-550-07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T18:57:16.539Z</lastUpdated>
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    <udiDi>08809978120022</udiDi>
    <basicUdiDi>08809978120022YH</basicUdiDi>
    <tradeName>Camera, still, surgical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000047814</manufacturerSrn>
    <authorisedRepresentativeName>SMGeurope OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000048466</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mark002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:06:52.948Z</lastUpdated>
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    <tradeName>Camera, still, surgical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000047814</manufacturerSrn>
    <authorisedRepresentativeName>SMGeurope OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000048466</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Meta001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:06:50.093Z</lastUpdated>
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    <udiDi>08809978120008</udiDi>
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    <tradeName>Camera, still, surgical</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI Plus Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000047814</manufacturerSrn>
    <authorisedRepresentativeName>SMGeurope OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000048466</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mark001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:06:48.148Z</lastUpdated>
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    <udiDi>08559970069996</udiDi>
    <basicUdiDi>08559970069999D</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL1 Polarized Spacer</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL1S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:18.194Z</lastUpdated>
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    <basicUdiDi>08559970069828U</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL100 Spacer</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL100S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:15.585Z</lastUpdated>
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    <udiDi>08559970069750</udiDi>
    <basicUdiDi>08559970069758X</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL100 Battery</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL100B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:13.988Z</lastUpdated>
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    <udiDi>08559970069682</udiDi>
    <basicUdiDi>085599700696892</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL100 Lens</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL100L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:11.598Z</lastUpdated>
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    <udiDi>08559970069514</udiDi>
    <basicUdiDi>08559970069518H</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL100 Center Polarizer Assembly</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL100CP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:09.982Z</lastUpdated>
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    <udiDi>08559970069446</udiDi>
    <basicUdiDi>08559970069448L</basicUdiDi>
    <tradeName>DERMLITE</tradeName>
    <deviceName>DL2 Battery</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLIIB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:09.197Z</lastUpdated>
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    <udiDi>08559970069378</udiDi>
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    <tradeName>DERMLITE</tradeName>
    <deviceName>DL Connection Kit for iPhone XS Max</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DLCKiXSM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:06.782Z</lastUpdated>
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    <udiDi>08559970069200</udiDi>
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    <tradeName>DERMLITE</tradeName>
    <deviceName>DL200 Snap-On Faceplate</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL200SOS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:04.378Z</lastUpdated>
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    <tradeName>DERMLITE</tradeName>
    <deviceName>DL200 Small Area Contact Plate</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL200SCP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:02.776Z</lastUpdated>
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    <tradeName>DERMLITE</tradeName>
    <deviceName>Universal Camera Adapter</deviceName>
    <manufacturerName>DermLite LLC</manufacturerName>
    <manufacturerSrn>US-MF-000005170</manufacturerSrn>
    <authorisedRepresentativeName>E C REP LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003995</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040108</emdnCode>
    <emdnDescription>DERMATOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-UNI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:45:01.980Z</lastUpdated>
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