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    <tradeName>06974482530413</tradeName>
    <deviceName>Disposable Ophthalmic Needle Holders</deviceName>
    <manufacturerName>OPHMED CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032262</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S12011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:48.582Z</lastUpdated>
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    <udiDi>06976939130801</udiDi>
    <basicUdiDi>B-06976939130801</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Needle holder blunt with lock</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC62</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:57.512Z</lastUpdated>
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    <udiDi>06976939130795</udiDi>
    <basicUdiDi>B-06976939130795</basicUdiDi>
    <tradeName>Surgitrac</tradeName>
    <deviceName>Suture needle holder curved</deviceName>
    <manufacturerName>Sihong Surgitrac Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041149</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC61</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:03:57.138Z</lastUpdated>
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    <udiDi>06974482534619</udiDi>
    <basicUdiDi>B-06974482534619</basicUdiDi>
    <tradeName>06974482534619</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPHMED CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032262</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S31592</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:18:09.870Z</lastUpdated>
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    <udiDi>06974482530505</udiDi>
    <basicUdiDi>B-06974482530505</basicUdiDi>
    <tradeName>06974482530505</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPHMED CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032262</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S31239</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:17:10.271Z</lastUpdated>
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  <row>
    <udiDi>06974482530482</udiDi>
    <basicUdiDi>B-06974482530482</basicUdiDi>
    <tradeName>06974482530482</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPHMED CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032262</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S12193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:17:09.473Z</lastUpdated>
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    <udiDi>06974482530451</udiDi>
    <basicUdiDi>B-06974482530451</basicUdiDi>
    <tradeName>06974482530451</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPHMED CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032262</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S12176</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:17:08.672Z</lastUpdated>
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    <udiDi>06974482530444</udiDi>
    <basicUdiDi>B-06974482530444</basicUdiDi>
    <tradeName>06974482530444</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPHMED CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000032262</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S12101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:17:05.473Z</lastUpdated>
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    <udiDi>05404027420936</udiDi>
    <basicUdiDi>B-05404027420936</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName>552017x10: Sterile, Single Use, Needle Holder, 9mm Curved Jaws, Flat Handle Without Lock, 125mm</deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552017</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:30:42.604Z</lastUpdated>
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    <udiDi>05404027406107</udiDi>
    <basicUdiDi>B-05404027406107</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName>552017: Sterile, Single Use, Needle Holder, 9mm Curved Jaws, Flat Handle Without Lock, 125mm</deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552017</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:30:28.381Z</lastUpdated>
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  <row>
    <udiDi>06975044450743</udiDi>
    <basicUdiDi>697504445HOLDERPH</basicUdiDi>
    <tradeName>Needle Holder</tradeName>
    <deviceName>Disposable Ophthalmic Holder</deviceName>
    <manufacturerName>Sihong Ophsurin Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037458</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3 -S140-H11P(SH-12205-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:20.763Z</lastUpdated>
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  <row>
    <udiDi>06975044450613</udiDi>
    <basicUdiDi>697504445MOSQUITOSG</basicUdiDi>
    <tradeName>Needle Holder</tradeName>
    <deviceName>Disposable Ophthalmic Holder</deviceName>
    <manufacturerName>Sihong Ophsurin Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037458</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-C115-H1N(SH-32008-1)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:56:16.761Z</lastUpdated>
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  <row>
    <udiDi>05404027421094</udiDi>
    <basicUdiDi>B-05404027421094</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>652021</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:37.938Z</lastUpdated>
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  <row>
    <udiDi>05404027421087</udiDi>
    <basicUdiDi>B-05404027421087</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552032</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:37.035Z</lastUpdated>
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  <row>
    <udiDi>05404027421070</udiDi>
    <basicUdiDi>B-05404027421070</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552031</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:36.135Z</lastUpdated>
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  <row>
    <udiDi>05404027421063</udiDi>
    <basicUdiDi>B-05404027421063</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552030</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:35.247Z</lastUpdated>
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    <udiDi>05404027421056</udiDi>
    <basicUdiDi>B-05404027421056</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552029</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:34.344Z</lastUpdated>
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  <row>
    <udiDi>05404027421049</udiDi>
    <basicUdiDi>B-05404027421049</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552028</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:33.439Z</lastUpdated>
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  <row>
    <udiDi>05404027421032</udiDi>
    <basicUdiDi>B-05404027421032</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552027</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:32.552Z</lastUpdated>
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    <udiDi>05404027421025</udiDi>
    <basicUdiDi>B-05404027421025</basicUdiDi>
    <tradeName>HASA OPTIX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HASA OPTIX</manufacturerName>
    <manufacturerSrn>BE-MF-000028219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q021105</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY NEEDLE HOLDERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552026</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T04:28:31.633Z</lastUpdated>
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