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    <tradeName>00195278210890</tradeName>
    <deviceName>Centricity™ High Acuity (CHA) Critical Care</deviceName>
    <manufacturerName>GE Healthcare Finland Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020282</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>K1900EBED</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:37.090Z</lastUpdated>
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    <udiDi>00195278125583</udiDi>
    <basicUdiDi>B-00195278125583</basicUdiDi>
    <tradeName>CBS Reusable Absorber Canister</tradeName>
    <deviceName>CBS Reusable Absorber Canister</deviceName>
    <manufacturerName>Datex-Ohmeda Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000014656</manufacturerSrn>
    <authorisedRepresentativeName>GE Healthcare Finland Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000017101</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203010180</emdnCode>
    <emdnDescription>ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2071165-001-S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:35.175Z</lastUpdated>
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    <udiDi>00195278118295</udiDi>
    <basicUdiDi>B-00195278118295</basicUdiDi>
    <tradeName>StarGuide</tradeName>
    <deviceName>StarGuide</deviceName>
    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
    <manufacturerSrn>IL-MF-000003062</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11020201</emdnCode>
    <emdnDescription>CT/GAMMA CAMERA SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3911AA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:34.369Z</lastUpdated>
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    <udiDi>00195278022653</udiDi>
    <basicUdiDi>B-00195278022653</basicUdiDi>
    <tradeName>00195278022653</tradeName>
    <deviceName>Gas exhaust line, white conical, disposable, 2m/6.6 ft</deviceName>
    <manufacturerName>GE Healthcare Finland Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1203020285</emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5514184</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:32.773Z</lastUpdated>
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    <udiDi>00195278021601</udiDi>
    <basicUdiDi>B-00195278021601</basicUdiDi>
    <tradeName>Vscan Air CL</tradeName>
    <deviceName>Vscan Air CL</deviceName>
    <manufacturerName>GE Vingmed Ultrasound AS</manufacturerName>
    <manufacturerSrn>NO-MF-000000553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP000158</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:30.363Z</lastUpdated>
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    <udiDi>00195278011343</udiDi>
    <basicUdiDi>B-00195278011343</basicUdiDi>
    <tradeName>DaTQUANT</tradeName>
    <deviceName>DaTQUANT</deviceName>
    <manufacturerName>GE Medical Systems Israel, Functional Imaging</manufacturerName>
    <manufacturerSrn>IL-MF-000003062</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000344</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H3901ZD</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:28.756Z</lastUpdated>
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    <udiDi>00195126000109</udiDi>
    <basicUdiDi>B-00195126000109</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Circulating Calprotectin Controls</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152011</emdnCode>
    <emdnDescription>CONTROLS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701367</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:27.951Z</lastUpdated>
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    <udiDi>00195126000093</udiDi>
    <basicUdiDi>B-00195126000093</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Circulating Calprotectin Calibrators</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152211</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701366</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:26.350Z</lastUpdated>
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    <udiDi>00195126000086</udiDi>
    <basicUdiDi>B-00195126000086</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Circulating Calprotectin Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701365</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:23.947Z</lastUpdated>
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    <udiDi>00184360000358</udiDi>
    <basicUdiDi>B-00184360000358</basicUdiDi>
    <tradeName>Revolution 45MHz Rotational Imaging Catheter</tradeName>
    <deviceName>Revolution</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020102</emdnCode>
    <emdnDescription>INTRAVASCULAR ULTRASOUND CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>89000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:22.356Z</lastUpdated>
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    <udiDi>00184360000341</udiDi>
    <basicUdiDi>B-00184360000341</basicUdiDi>
    <tradeName>ComboWire Pressure/Flow Guide Wire</tradeName>
    <deviceName>ComboWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9500</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:21.546Z</lastUpdated>
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    <udiDi>00184360000334</udiDi>
    <basicUdiDi>B-00184360000334</basicUdiDi>
    <tradeName>ComboWire Pressure/Flow Guide Wire</tradeName>
    <deviceName>ComboWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9515</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:19.944Z</lastUpdated>
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    <udiDi>00184360000327</udiDi>
    <basicUdiDi>B-00184360000327</basicUdiDi>
    <tradeName>R-100</tradeName>
    <deviceName>R-100</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0180</emdnCode>
    <emdnDescription>ARTERO-VENOUS SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>804547001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:17.546Z</lastUpdated>
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    <udiDi>00184360000150</udiDi>
    <basicUdiDi>B-00184360000150</basicUdiDi>
    <tradeName>FloWire Doppler Guide Wire</tradeName>
    <deviceName>FloWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1403</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:15.939Z</lastUpdated>
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    <udiDi>00184360000129</udiDi>
    <basicUdiDi>B-00184360000129</basicUdiDi>
    <tradeName>FloWire Doppler Guide Wire</tradeName>
    <deviceName>FloWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1400J</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:15.140Z</lastUpdated>
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    <udiDi>00184360000112</udiDi>
    <basicUdiDi>B-00184360000112</basicUdiDi>
    <tradeName>FloWire Doppler Guide Wire</tradeName>
    <deviceName>FloWire</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04030101</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1400</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:13.545Z</lastUpdated>
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    <udiDi>00180668000366</udiDi>
    <basicUdiDi>B-00180668000366</basicUdiDi>
    <tradeName>14cm ProACT Single- INTL</tradeName>
    <deviceName>14cm ProACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800022-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:11.152Z</lastUpdated>
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    <udiDi>00184360000037</udiDi>
    <basicUdiDi>B-00184360000037</basicUdiDi>
    <tradeName>Visions PV .018 Digital IVUS Catheter</tradeName>
    <deviceName>Visions PV</deviceName>
    <manufacturerName>Volcano Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000020094</manufacturerSrn>
    <authorisedRepresentativeName>Volcano Europe</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000929</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020102</emdnCode>
    <emdnDescription>INTRAVASCULAR ULTRASOUND CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86700</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:09.556Z</lastUpdated>
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    <udiDi>00180668000342</udiDi>
    <basicUdiDi>B-00180668000342</basicUdiDi>
    <tradeName>9cm ACT Single- INTL</tradeName>
    <deviceName>9cm ACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800021-05</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:08.737Z</lastUpdated>
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    <udiDi>00180668000359</udiDi>
    <basicUdiDi>B-00180668000359</basicUdiDi>
    <tradeName>12cm ProACT Single- INTL</tradeName>
    <deviceName>12cm ProACT Single- INTL</deviceName>
    <manufacturerName>Uromedica, Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000008932</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P080199</emdnCode>
    <emdnDescription>URINARY INCONTINENCE PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800022-01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:07:07.140Z</lastUpdated>
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