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    <tradeName>Serene Bariatric</tradeName>
    <deviceName>Serene Bariatric</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-079000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:36.142Z</lastUpdated>
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    <udiDi>04719893345384</udiDi>
    <basicUdiDi>B-04719893345384</basicUdiDi>
    <tradeName>Domus Auto</tradeName>
    <deviceName>Domus Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077520</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:14.480Z</lastUpdated>
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    <udiDi>04719893345261</udiDi>
    <basicUdiDi>B-04719893345261</basicUdiDi>
    <tradeName>Domus Auto</tradeName>
    <deviceName>Domus Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077520</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:13.674Z</lastUpdated>
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    <udiDi>04719893332469</udiDi>
    <basicUdiDi>B-04719893332469</basicUdiDi>
    <tradeName>04719893332469</tradeName>
    <deviceName>Mattress</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9M676003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:08.056Z</lastUpdated>
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    <udiDi>04719893331387</udiDi>
    <basicUdiDi>B-04719893331387</basicUdiDi>
    <tradeName>04719893331387</tradeName>
    <deviceName>Mattress</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9M504046</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:07.266Z</lastUpdated>
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    <udiDi>04719893331240</udiDi>
    <basicUdiDi>B-04719893331240</basicUdiDi>
    <tradeName>04719893331240</tradeName>
    <deviceName>Mattress</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9M504040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:06.469Z</lastUpdated>
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    <udiDi>04719893313475</udiDi>
    <basicUdiDi>B-04719893313475</basicUdiDi>
    <tradeName>Optima Auto</tradeName>
    <deviceName>Optima Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-086520</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:05.664Z</lastUpdated>
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    <udiDi>04719893312843</udiDi>
    <basicUdiDi>B-04719893312843</basicUdiDi>
    <tradeName>04719893312843</tradeName>
    <deviceName>Pro-care Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-087520</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:00.866Z</lastUpdated>
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    <udiDi>04719893312614</udiDi>
    <basicUdiDi>B-04719893312614</basicUdiDi>
    <tradeName>Domus Auto</tradeName>
    <deviceName>9P-077520</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077520</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:01:00.067Z</lastUpdated>
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    <udiDi>04719893312577</udiDi>
    <basicUdiDi>B-04719893312577</basicUdiDi>
    <tradeName>Domus Auto</tradeName>
    <deviceName>Domus Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077520</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:00:59.269Z</lastUpdated>
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    <udiDi>04719893312560</udiDi>
    <basicUdiDi>B-04719893312560</basicUdiDi>
    <tradeName>Domus 4</tradeName>
    <deviceName>Domus 4</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:00:58.471Z</lastUpdated>
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    <udiDi>04719893312027</udiDi>
    <basicUdiDi>B-04719893312027</basicUdiDi>
    <tradeName>Domus 4</tradeName>
    <deviceName>Domus 4</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:00:53.669Z</lastUpdated>
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    <udiDi>04719893310191</udiDi>
    <basicUdiDi>B-04719893310191</basicUdiDi>
    <tradeName>Domus 3</tradeName>
    <deviceName>Domus 3</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-074540</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:00:52.884Z</lastUpdated>
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    <udiDi>04713025009458</udiDi>
    <basicUdiDi>B-04713025009458</basicUdiDi>
    <tradeName>Domus Auto</tradeName>
    <deviceName>Domus Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077520</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:49:59.939Z</lastUpdated>
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    <udiDi>04713025009427</udiDi>
    <basicUdiDi>B-04713025009427</basicUdiDi>
    <tradeName>Domus Auto</tradeName>
    <deviceName>Domus Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077520</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:49:58.352Z</lastUpdated>
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    <udiDi>04713025006853</udiDi>
    <basicUdiDi>B-04713025006853</basicUdiDi>
    <tradeName>Optima Auto</tradeName>
    <deviceName>Optima Auto</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-086530</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:49:55.942Z</lastUpdated>
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    <udiDi>04713025006686</udiDi>
    <basicUdiDi>B-04713025006686</basicUdiDi>
    <tradeName>04713025006686</tradeName>
    <deviceName>Mattress</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9M036004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:49:54.340Z</lastUpdated>
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    <udiDi>04713025006334</udiDi>
    <basicUdiDi>B-04713025006334</basicUdiDi>
    <tradeName>Domus Auto Bariatric</tradeName>
    <deviceName>Domus Auto Bariatric</deviceName>
    <manufacturerName>Wellell Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000009159</manufacturerSrn>
    <authorisedRepresentativeName>Wellell Iberia S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000003668</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V080701</emdnCode>
    <emdnDescription>ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9P-077520</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:49:53.552Z</lastUpdated>
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    <udiDi>05407009800009</udiDi>
    <basicUdiDi>540700980BELT83</basicUdiDi>
    <tradeName>Roll Belt with 2 side straps Small/Medium</tradeName>
    <deviceName>Restraining system</deviceName>
    <manufacturerName>RENOL</manufacturerName>
    <manufacturerSrn>BE-MF-000000785</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0804</emdnCode>
    <emdnDescription>PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFB09115</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:44:42.929Z</lastUpdated>
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    <udiDi>05407009800016</udiDi>
    <basicUdiDi>540700980BELT83</basicUdiDi>
    <tradeName>Roll Belt with 2 side straps Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RENOL</manufacturerName>
    <manufacturerSrn>BE-MF-000000785</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>RFB09140</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:44:42.903Z</lastUpdated>
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