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    <basicUdiDi>912004788-HSOOPFIX-N7</basicUdiDi>
    <tradeName>09120047885079</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rudolf Heintel Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000050568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSOOPFIX1000P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:34.280Z</lastUpdated>
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    <udiDi>09120047885093</udiDi>
    <basicUdiDi>912004788-HSOOPFIX-N7</basicUdiDi>
    <tradeName>09120047885093</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rudolf Heintel Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000050568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSOOPFIX800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:34.256Z</lastUpdated>
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    <udiDi>09120047885178</udiDi>
    <basicUdiDi>912004788-HSOSAFIX-JN</basicUdiDi>
    <tradeName>09120047885178</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rudolf Heintel Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000050568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSOSAFIX2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:34.153Z</lastUpdated>
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    <udiDi>09120047885192</udiDi>
    <basicUdiDi>912004788-HSOSAFIX-JN</basicUdiDi>
    <tradeName>09120047885192</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rudolf Heintel Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000050568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSOSAFIX3000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:34.128Z</lastUpdated>
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    <udiDi>09120047885215</udiDi>
    <basicUdiDi>912004788-HSOSAFIX-JN</basicUdiDi>
    <tradeName>09120047885215</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rudolf Heintel Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000050568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSOSAFIX4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:34.090Z</lastUpdated>
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    <udiDi>09120047885239</udiDi>
    <basicUdiDi>912004788-HSOSAFIX-JN</basicUdiDi>
    <tradeName>09120047885239</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rudolf Heintel Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000050568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSOSAFIX5000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:34.071Z</lastUpdated>
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    <udiDi>09120047885253</udiDi>
    <basicUdiDi>912004788-HSOSAFIX-JN</basicUdiDi>
    <tradeName>09120047885253</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rudolf Heintel Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000050568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSOSAFIX5000L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:58:34.049Z</lastUpdated>
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    <udiDi>08053847360174</udiDi>
    <basicUdiDi>B-08053847360174</basicUdiDi>
    <tradeName>BABY HEAD IMMOBILIZER</tradeName>
    <deviceName>BABY HEAD IMMOBILIZER WITH VENTILATOR HOSE HOLDER</deviceName>
    <manufacturerName>GINEVRI srl</manufacturerName>
    <manufacturerSrn>IT-MF-000034527</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7749</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T17:03:09.202Z</lastUpdated>
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    <udiDi>08053847360181</udiDi>
    <basicUdiDi>B-08053847360181</basicUdiDi>
    <tradeName>BABY HEAD IMMOBILIZER</tradeName>
    <deviceName>BABY HEAD IMMOBILIZER WITH VENTILATOR TUBE HOLDER</deviceName>
    <manufacturerName>GINEVRI srl</manufacturerName>
    <manufacturerSrn>IT-MF-000034527</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7647</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T17:03:07.609Z</lastUpdated>
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    <udiDi>03760035442936</udiDi>
    <basicUdiDi>B-03760035442936</basicUdiDi>
    <tradeName>STABINECK C2</tradeName>
    <deviceName>STABINECK C2</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STABINECK C2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:22:55.112Z</lastUpdated>
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    <udiDi>03760035442929</udiDi>
    <basicUdiDi>B-03760035442929</basicUdiDi>
    <tradeName>STABINECK C2</tradeName>
    <deviceName>STABINECK C2</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STABINECK C2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:22:53.519Z</lastUpdated>
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    <udiDi>03760035441977</udiDi>
    <basicUdiDi>B-03760035441977</basicUdiDi>
    <tradeName>STABINECK C2</tradeName>
    <deviceName>STABINECK C2</deviceName>
    <manufacturerName>GROUPE SOBER SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000017818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STABINECK C2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:22:51.112Z</lastUpdated>
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  <row>
    <udiDi>04900070937410</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93741</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.479Z</lastUpdated>
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    <udiDi>04900070937427</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93742</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.465Z</lastUpdated>
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  <row>
    <udiDi>04900070938219</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93821</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.451Z</lastUpdated>
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  <row>
    <udiDi>04900070938226</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>93822</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.436Z</lastUpdated>
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    <udiDi>04900070942322</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94232</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.423Z</lastUpdated>
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    <udiDi>04900070945118</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94511</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.410Z</lastUpdated>
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  <row>
    <udiDi>04900070945125</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94512</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.387Z</lastUpdated>
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  <row>
    <udiDi>04900070945217</udiDi>
    <basicUdiDi>49000700000001AK</basicUdiDi>
    <tradeName>MOLDCARE RI II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ALCARE Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000006483</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>94521</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:18:13.371Z</lastUpdated>
  </row>
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