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    <tradeName>05902643979482</tradeName>
    <deviceName>VX FACTOR (K) E171051</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080502</emdnCode>
    <emdnDescription>IMPREGNATED DISKS, MULTI-DISKS &amp; TABLETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E171051 (K)</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:45.750Z</lastUpdated>
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    <udiDi>05902643974005</udiDi>
    <basicUdiDi>59026439BBMTGCK9</basicUdiDi>
    <tradeName>TIGECYCLINE</tradeName>
    <deviceName>MIC test TIGECYCLINE</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0150B10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:44.943Z</lastUpdated>
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    <udiDi>05902643971622</udiDi>
    <basicUdiDi>59026439BFMAMBJ6</basicUdiDi>
    <tradeName>AMPHOTERICIN B</tradeName>
    <deviceName>MIC test AMPHOTERICIN B</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0162F05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:44.129Z</lastUpdated>
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    <udiDi>05902643971585</udiDi>
    <basicUdiDi>59026439BBMVAL3</basicUdiDi>
    <tradeName>VANCOMYCIN</tradeName>
    <deviceName>MIC test VANCOMYCIN</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0158B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:43.330Z</lastUpdated>
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    <udiDi>05902643971462</udiDi>
    <basicUdiDi>59026439BBMTEL5</basicUdiDi>
    <tradeName>TETRACYCLINE</tradeName>
    <deviceName>MIC test TETRACYCLINE</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0146B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:42.545Z</lastUpdated>
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    <udiDi>05902643971417</udiDi>
    <basicUdiDi>59026439BBMTECK3</basicUdiDi>
    <tradeName>TEICOPLANIN</tradeName>
    <deviceName>MIC test TEICOPLANIN</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0141B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:41.745Z</lastUpdated>
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    <udiDi>05902643971363</udiDi>
    <basicUdiDi>59026439BBMSPE</basicUdiDi>
    <tradeName>STREPTOMYCIN</tradeName>
    <deviceName>MIC test STREPTOMYCIN</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0136B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:40.942Z</lastUpdated>
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    <udiDi>05902643971295</udiDi>
    <basicUdiDi>59026439BBMRAKP</basicUdiDi>
    <tradeName>RIFAMPICIN</tradeName>
    <deviceName>MIC test RIFAMPICIN</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0129B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:40.126Z</lastUpdated>
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    <udiDi>05902643971233</udiDi>
    <basicUdiDi>59026439BBMTZPMU</basicUdiDi>
    <tradeName>PIPERACILLIN-TAZOBACTAM</tradeName>
    <deviceName>MIC test PIPERACILLIN-TAZOBACTAM</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0123B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:39.346Z</lastUpdated>
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    <udiDi>05902643971226</udiDi>
    <basicUdiDi>59026439BBMPRLL8</basicUdiDi>
    <tradeName>PIPERACILLIN</tradeName>
    <deviceName>MIC test PIPERACILLIN</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0122B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:38.531Z</lastUpdated>
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    <udiDi>05902643971202</udiDi>
    <basicUdiDi>59026439BBMPP8</basicUdiDi>
    <tradeName>PENICILLIN G</tradeName>
    <deviceName>MIC test PENICILLIN G</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0120B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:37.725Z</lastUpdated>
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    <udiDi>05902643971141</udiDi>
    <basicUdiDi>59026439BBMOXLU</basicUdiDi>
    <tradeName>OXACILLIN</tradeName>
    <deviceName>MIC test OXACILLIN</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0114B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:36.932Z</lastUpdated>
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    <udiDi>05902643970076</udiDi>
    <basicUdiDi>59026439BBMSAMK6</basicUdiDi>
    <tradeName>AMPICILLIN-SULBACTAM</tradeName>
    <deviceName>MIC test AMPICILLIN-SULBACTAM</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080501</emdnCode>
    <emdnDescription>MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007B05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:36.165Z</lastUpdated>
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    <udiDi>05902643962279</udiDi>
    <basicUdiDi>59026439CBCH814BT</basicUdiDi>
    <tradeName>05902643962279</tradeName>
    <deviceName>BioPath R</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-814-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:35.335Z</lastUpdated>
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    <udiDi>05902643962262</udiDi>
    <basicUdiDi>59026439CBCH813BR</basicUdiDi>
    <tradeName>05902643962262</tradeName>
    <deviceName>BioNorm R</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-813-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:34.551Z</lastUpdated>
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    <udiDi>05902643962255</udiDi>
    <basicUdiDi>59026439CBCH812BP</basicUdiDi>
    <tradeName>05902643962255</tradeName>
    <deviceName>KONTROLA CRP - Poziom 2 (1 ml)</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-812-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:33.746Z</lastUpdated>
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    <udiDi>05902643962248</udiDi>
    <basicUdiDi>59026439CBCH811BM</basicUdiDi>
    <tradeName>05902643962248</tradeName>
    <deviceName>KONTROLA CRP - Poziom 1 (1 ml)</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-811-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:32.932Z</lastUpdated>
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    <deviceName>BioCal (4x3 ml)</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-803-0012</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:32.126Z</lastUpdated>
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    <basicUdiDi>59026439CBCH781C5</basicUdiDi>
    <tradeName>05902643962187</tradeName>
    <deviceName>Kalibrator CK-MB</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-781-0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:31.319Z</lastUpdated>
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    <udiDi>05902643961807</udiDi>
    <basicUdiDi>59026439CBCH238BB</basicUdiDi>
    <tradeName>05902643961807</tradeName>
    <deviceName>CK-MB BM 100 / BM 200</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-238-0060</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:28:30.524Z</lastUpdated>
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