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    <tradeName>Helical Drill  4,3mm with Stop</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805080</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.616Z</lastUpdated>
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    <udiDi>*+D9948050810C*</udiDi>
    <basicUdiDi>B-*+D9948050810C*</basicUdiDi>
    <tradeName>Helical Drill  4,5mm with Stop</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805081</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.589Z</lastUpdated>
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    <udiDi>*+D9948050820D*</udiDi>
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    <tradeName>Tapered Drill  3,5mm for Dense Bone with Stop</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805082</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.559Z</lastUpdated>
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    <udiDi>*+D9948050830E*</udiDi>
    <basicUdiDi>B-*+D9948050830E*</basicUdiDi>
    <tradeName>Drill for Fixation Pin 1,3mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805083</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.529Z</lastUpdated>
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    <udiDi>*+D9948050850G*</udiDi>
    <basicUdiDi>B-*+D9948050850G*</basicUdiDi>
    <tradeName>Lance Drill 2,0 x 4,0mm Sleeve 3,5 Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805085</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.501Z</lastUpdated>
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  <row>
    <udiDi>*+D9948050860H*</udiDi>
    <basicUdiDi>B-*+D9948050860H*</basicUdiDi>
    <tradeName>Lance Drill 2,0 x 8,5mm Sleeve 3,5 Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805086</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.482Z</lastUpdated>
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    <udiDi>*+D9948050870I*</udiDi>
    <basicUdiDi>B-*+D9948050870I*</basicUdiDi>
    <tradeName>Tapered Drill 3,5 x 8,5mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805087</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.456Z</lastUpdated>
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    <udiDi>*+D9948050880J*</udiDi>
    <basicUdiDi>B-*+D9948050880J*</basicUdiDi>
    <tradeName>Tapered Drill 3,5 x 10mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805088</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.444Z</lastUpdated>
  </row>
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    <udiDi>*+D9948050890K*</udiDi>
    <basicUdiDi>B-*+D9948050890K*</basicUdiDi>
    <tradeName>Tapered Drill 3,5 x 11,5mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805089</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.426Z</lastUpdated>
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  <row>
    <udiDi>*+D9948050900C*</udiDi>
    <basicUdiDi>B-*+D9948050900C*</basicUdiDi>
    <tradeName>Tapered Drill 3,5 x 13mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805090</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.407Z</lastUpdated>
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    <udiDi>*+D9948050920E*</udiDi>
    <basicUdiDi>B-*+D9948050920E*</basicUdiDi>
    <tradeName>Lance Drill 2,0 x 4,0 Sleeve 4,3 Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805092</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.381Z</lastUpdated>
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    <udiDi>*+D9948050930F*</udiDi>
    <basicUdiDi>B-*+D9948050930F*</basicUdiDi>
    <tradeName>Lance Drill 2,8 x 8,5 Sleeve 4,3 Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805093</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.356Z</lastUpdated>
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    <udiDi>*+D9948050940G*</udiDi>
    <basicUdiDi>B-*+D9948050940G*</basicUdiDi>
    <tradeName>Tapered Drill 4,3 x 8,5mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805094</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.329Z</lastUpdated>
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    <udiDi>*+D9948050950H*</udiDi>
    <basicUdiDi>B-*+D9948050950H*</basicUdiDi>
    <tradeName>Tapered Drill 4,3 x 10mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805095</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.309Z</lastUpdated>
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    <udiDi>*+D9948050960I*</udiDi>
    <basicUdiDi>B-*+D9948050960I*</basicUdiDi>
    <tradeName>Tapered Drill 4,3 x 11,5mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805096</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.288Z</lastUpdated>
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    <udiDi>*+D9948050970J*</udiDi>
    <basicUdiDi>B-*+D9948050970J*</basicUdiDi>
    <tradeName>Tapered Drill 4,3 x 13mm Guide</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805097</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.273Z</lastUpdated>
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    <udiDi>*+D99480512006*</udiDi>
    <basicUdiDi>B-*+D99480512006*</basicUdiDi>
    <tradeName>Tapered Drill  3,0mm for Dense Bone</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805120</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.249Z</lastUpdated>
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    <udiDi>*+D99480512107*</udiDi>
    <basicUdiDi>B-*+D99480512107*</basicUdiDi>
    <tradeName>Tapered Drill  3,0mm for Dense Bone with Stop</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805121</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.225Z</lastUpdated>
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    <udiDi>*+D99480512208*</udiDi>
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    <tradeName>Tapered Drill 3,8mm</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805122</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.207Z</lastUpdated>
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    <udiDi>*+D99480512309*</udiDi>
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    <tradeName>Tapered Drill 3,8mm with Stop</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805123</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.188Z</lastUpdated>
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