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    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 3410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:58.603Z</lastUpdated>
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    <udiDi>06941850827345</udiDi>
    <basicUdiDi>69418508F1DP</basicUdiDi>
    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 3409</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:57.491Z</lastUpdated>
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    <udiDi>06941850827338</udiDi>
    <basicUdiDi>69418508F1DP</basicUdiDi>
    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 3408</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:56.677Z</lastUpdated>
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    <udiDi>06941850827321</udiDi>
    <basicUdiDi>69418508F1DP</basicUdiDi>
    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 3312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:53.821Z</lastUpdated>
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    <udiDi>06941850827314</udiDi>
    <basicUdiDi>69418508F1DP</basicUdiDi>
    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 3311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:52.868Z</lastUpdated>
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    <udiDi>06941850827307</udiDi>
    <basicUdiDi>69418508F1DP</basicUdiDi>
    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 3310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:51.399Z</lastUpdated>
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    <udiDi>06941850827291</udiDi>
    <basicUdiDi>69418508F1DP</basicUdiDi>
    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G3 3309</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:50.537Z</lastUpdated>
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    <udiDi>06941850827116</udiDi>
    <basicUdiDi>69418508HME1TU</basicUdiDi>
    <tradeName>Disposable Heat and Moisture Exchanger Filters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040199</emdnCode>
    <emdnDescription>VENTILATION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1 3102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:30:46.734Z</lastUpdated>
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    <udiDi>06923980102479</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter, 22F/15M, 22M/15F w/Luer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:43:59.462Z</lastUpdated>
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    <udiDi>06923980104763</udiDi>
    <basicUdiDi>69239801ND2ICPA</basicUdiDi>
    <tradeName>HMEF w/Luer,  22F/15M, 22/15mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0026</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:04.413Z</lastUpdated>
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    <udiDi>06923980105579</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter, HEPA w/luer, 22F/15M, 22/15mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.690Z</lastUpdated>
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    <udiDi>06923980105586</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter 22F/15M w/Luer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.674Z</lastUpdated>
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  <row>
    <udiDi>06923980105593</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter, 22F/15M, 22/15mm w/Luer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.647Z</lastUpdated>
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    <udiDi>06923980105609</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter, 22F/15M, 22/15mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0007</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.628Z</lastUpdated>
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    <udiDi>06923980105616</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter, 30F, 30M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0008</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.607Z</lastUpdated>
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    <udiDi>06923980105623</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Filter, 30F, 30M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0009</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.580Z</lastUpdated>
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    <udiDi>06923980105630</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Exhalometer filter, 30F, 30M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105647</udiDi>
    <basicUdiDi>69239801ND2IBP8</basicUdiDi>
    <tradeName>Filter, 22F, 22/15mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF0016</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.533Z</lastUpdated>
  </row>
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    <udiDi>06923980105654</udiDi>
    <basicUdiDi>69239801ND2IAP6</basicUdiDi>
    <tradeName>Electrostatic Breathing Filter ID22/OD15</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XHM0011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923980105661</udiDi>
    <basicUdiDi>69239801ND2ICPA</basicUdiDi>
    <tradeName>HMEF, 22F/15M, 22/15mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GaleMed (Xiamen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020627</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R040101</emdnCode>
    <emdnDescription>ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH0025</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:34:03.497Z</lastUpdated>
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