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    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000038391</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:04:46.366Z</lastUpdated>
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    <udiDi>08800079000008</udiDi>
    <basicUdiDi>B-08800079000008</basicUdiDi>
    <tradeName>08800079000008</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HULASER</manufacturerName>
    <manufacturerSrn>KR-MF-000008621</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PK2M-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:05:40.511Z</lastUpdated>
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    <udiDi>07540261014222</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C100 Airwave Oscillometry System - Nose Clip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101422</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.156Z</lastUpdated>
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    <udiDi>07540261016356</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>clearflo F-100 - 100 Airwave Oscillometry Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101635</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.118Z</lastUpdated>
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    <udiDi>07540261016646</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C2 Sensor Module - ClearFlo Compatible</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101664</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.103Z</lastUpdated>
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    <udiDi>07540261016882</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C2 Support Arm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101688</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.091Z</lastUpdated>
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    <udiDi>07540261019470</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo Molded Test Load 15R - Characterized</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101947</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.026Z</lastUpdated>
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    <udiDi>07540261020360</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C2 Airwave Oscillometry System &amp; Accessories</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.005Z</lastUpdated>
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    <udiDi>07540261022326</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C2 Sensor Module - ClearFlo Compatible</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102232</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:06.913Z</lastUpdated>
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    <udiDi>07540261022333</udiDi>
    <basicUdiDi>7540261tremofloC2N6</basicUdiDi>
    <tradeName>tremoflo C2 Sensor Module - ClearFlo Compatible</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THORASYS Thoracic Medical Systems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000039221</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R0499</emdnCode>
    <emdnDescription>RESPIRATORY FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102233</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:06.904Z</lastUpdated>
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    <udiDi>35061122260303</udiDi>
    <basicUdiDi>B-35061122260303</basicUdiDi>
    <tradeName>35061122260303</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000038391</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:15:54.442Z</lastUpdated>
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    <udiDi>35061122260716</udiDi>
    <basicUdiDi>B-35061122260716</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000038391</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:15:54.430Z</lastUpdated>
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    <udiDi>45061122260300</udiDi>
    <basicUdiDi>B-45061122260300</basicUdiDi>
    <tradeName>45061122260300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000038391</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:11:10.355Z</lastUpdated>
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    <udiDi>55061122260307</udiDi>
    <basicUdiDi>B-55061122260307</basicUdiDi>
    <tradeName>55061122260307</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000038391</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000019483</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:17:13.477Z</lastUpdated>
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    <udiDi>65061122260014</udiDi>
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    <tradeName>65061122260014</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000038391</manufacturerSrn>
    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDX-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:03:18.446Z</lastUpdated>
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    <udiDi>65061122260304</udiDi>
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    <tradeName>65061122260304</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
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    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T01:03:18.437Z</lastUpdated>
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    <udiDi>75061122260011</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <deviceName></deviceName>
    <manufacturerName>Shire Controls Ltd</manufacturerName>
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    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <manufacturerName>Shire Controls Ltd</manufacturerName>
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    <authorisedRepresentativeName>OMC NI MEDICAL LIMITED</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <reference>SA-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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