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    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33016-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:51:11.751Z</lastUpdated>
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    <udiDi>00813830025699</udiDi>
    <basicUdiDi>B-00813830025699</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33015-9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:51:10.944Z</lastUpdated>
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    <udiDi>00813830025682</udiDi>
    <basicUdiDi>B-00813830025682</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33015-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:51:09.334Z</lastUpdated>
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    <udiDi>00813830025675</udiDi>
    <basicUdiDi>B-00813830025675</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33015-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:51:06.954Z</lastUpdated>
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    <udiDi>00813830025668</udiDi>
    <basicUdiDi>B-00813830025668</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33015-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:51:05.355Z</lastUpdated>
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    <udiDi>00813830025651</udiDi>
    <basicUdiDi>B-00813830025651</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33015-14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:51:04.549Z</lastUpdated>
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    <udiDi>00813830025057</udiDi>
    <basicUdiDi>B-00813830025057</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27663</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:50:41.321Z</lastUpdated>
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    <udiDi>00813830023947</udiDi>
    <basicUdiDi>B-00813830023947</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27679</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:50:13.252Z</lastUpdated>
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  <row>
    <udiDi>00813830021554</udiDi>
    <basicUdiDi>B-00813830021554</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:49:41.238Z</lastUpdated>
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    <udiDi>00813830021561</udiDi>
    <basicUdiDi>B-00813830021561</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:49:38.828Z</lastUpdated>
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    <udiDi>00813830021547</udiDi>
    <basicUdiDi>B-00813830021547</basicUdiDi>
    <tradeName>Accutron Inc.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACCUTRON</manufacturerName>
    <manufacturerSrn>US-MF-000009363</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:49:37.346Z</lastUpdated>
  </row>
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    <udiDi>14250105629597</udiDi>
    <basicUdiDi>42501056-1.5.3-VR</basicUdiDi>
    <tradeName>Bi-Mask 3; 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35-65-223</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:25.170Z</lastUpdated>
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    <udiDi>14250105629603</udiDi>
    <basicUdiDi>42501056-1.5.3-VR</basicUdiDi>
    <tradeName>Bi-Mask 4; 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35-65-224</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:25.129Z</lastUpdated>
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    <udiDi>14250105629610</udiDi>
    <basicUdiDi>42501056-1.5.3-VR</basicUdiDi>
    <tradeName>Bi-Mask 5; 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35-65-225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:25.096Z</lastUpdated>
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    <udiDi>14250105629627</udiDi>
    <basicUdiDi>42501056-1.5.3-VR</basicUdiDi>
    <tradeName>Bi-Mask 6; 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>35-65-226</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:25.059Z</lastUpdated>
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    <udiDi>14250105630531</udiDi>
    <basicUdiDi>42501056-1.5.7-W5</basicUdiDi>
    <tradeName>Paediatric Mask; Infant #1; 15 mm O.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-11-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:24.717Z</lastUpdated>
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    <udiDi>14250105630548</udiDi>
    <basicUdiDi>42501056-1.5.7-W5</basicUdiDi>
    <tradeName>Paediatric Mask; Child; #2; 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>88-11-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:24.695Z</lastUpdated>
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    <udiDi>14250105630791</udiDi>
    <basicUdiDi>42501056-1.5.3-VR</basicUdiDi>
    <tradeName>ClearFlex™ plus Silicone anaesthetic face mask paediatric; 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8749222</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:24.614Z</lastUpdated>
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    <udiDi>14250105630807</udiDi>
    <basicUdiDi>42501056-1.5.3-VR</basicUdiDi>
    <tradeName>ClearFlex™ plus Silicone anaesthetic face mask small adult, 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8749333</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:24.591Z</lastUpdated>
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    <udiDi>14250105630814</udiDi>
    <basicUdiDi>42501056-1.5.3-VR</basicUdiDi>
    <tradeName>ClearFlex™ plus Silicone anaesthetic face mask medium adult, 22 mm I.D.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VBM Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8749444</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T11:49:24.558Z</lastUpdated>
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