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    <tradeName>omegapack Zestaw do operacji ortopedycznych 363</tradeName>
    <deviceName>omegapack Zestaw do operacji ortopedycznych 363</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-ORT-01363</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:35.724Z</lastUpdated>
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    <udiDi>05904109600404</udiDi>
    <basicUdiDi>B-05904109600404</basicUdiDi>
    <tradeName>omegapack Zestaw do cięcia cesarskiego 126</tradeName>
    <deviceName>omegapack Zestaw do cięcia cesarskiego 126</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-CES-02876</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:33.993Z</lastUpdated>
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    <udiDi>05904109600381</udiDi>
    <basicUdiDi>B-05904109600381</basicUdiDi>
    <tradeName>omegapack Zestaw do angiografii 103</tradeName>
    <deviceName>omegapack Zestaw do angiografii 103</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-ANG-02103</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:33.210Z</lastUpdated>
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    <udiDi>05904109600114</udiDi>
    <basicUdiDi>B-05904109600114</basicUdiDi>
    <tradeName>deltaset Pakiet do znieczuleń 129</tradeName>
    <deviceName>deltaset Pakiet do znieczuleń 129</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-ZNI-00729</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:32.402Z</lastUpdated>
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    <udiDi>05904063815432</udiDi>
    <basicUdiDi>B-05904063815432</basicUdiDi>
    <tradeName>05904063815432</tradeName>
    <deviceName>Komora do suchych kąpieli w dwutlenku węgla lub ozonie DUO DRY JET</deviceName>
    <manufacturerName>Biuro Handlowe Kinesis Andrzej Boruta</manufacturerName>
    <manufacturerSrn>PL-MF-000018445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Duo Dry Jet</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:28.391Z</lastUpdated>
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    <udiDi>05904063815425</udiDi>
    <basicUdiDi>B-05904063815425</basicUdiDi>
    <tradeName>05904063815425</tradeName>
    <deviceName>AQUANESIS E/A wanna do hydroterapii ogólnoustrojowej z dyszami</deviceName>
    <manufacturerName>Biuro Handlowe Kinesis Andrzej Boruta</manufacturerName>
    <manufacturerSrn>PL-MF-000018445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUANESIS E/A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:27.588Z</lastUpdated>
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    <udiDi>05904063815418</udiDi>
    <basicUdiDi>B-05904063815418</basicUdiDi>
    <tradeName>05904063815418</tradeName>
    <deviceName>AQUANESIS E/M wanna do hydroterapii ogólnoustrojowej  z wężem ręcznym</deviceName>
    <manufacturerName>Biuro Handlowe Kinesis Andrzej Boruta</manufacturerName>
    <manufacturerSrn>PL-MF-000018445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUANESIS E/M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:26.794Z</lastUpdated>
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    <udiDi>05904063815401</udiDi>
    <basicUdiDi>B-05904063815401</basicUdiDi>
    <tradeName>05904063815401</tradeName>
    <deviceName>AQUANESIS BP wanna do masażu wirowego kończyn dolnych i kręgosłupa</deviceName>
    <manufacturerName>Biuro Handlowe Kinesis Andrzej Boruta</manufacturerName>
    <manufacturerSrn>PL-MF-000018445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUANESIS BP</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:25.988Z</lastUpdated>
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    <udiDi>05904063815395</udiDi>
    <basicUdiDi>B-05904063815395</basicUdiDi>
    <tradeName>05904063815395</tradeName>
    <deviceName>AQUANESIS H wanna do masażu wirowego kończyn górnych</deviceName>
    <manufacturerName>Biuro Handlowe Kinesis Andrzej Boruta</manufacturerName>
    <manufacturerSrn>PL-MF-000018445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUANESIS H</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:21.986Z</lastUpdated>
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    <udiDi>05904063815388</udiDi>
    <basicUdiDi>B-05904063815388</basicUdiDi>
    <tradeName>05904063815388</tradeName>
    <deviceName>AQUANESIS P wanna do masażu wirowego kończyn dolnych</deviceName>
    <manufacturerName>Biuro Handlowe Kinesis Andrzej Boruta</manufacturerName>
    <manufacturerSrn>PL-MF-000018445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUANESIS P</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:21.192Z</lastUpdated>
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    <udiDi>05904063815371</udiDi>
    <basicUdiDi>B-05904063815371</basicUdiDi>
    <tradeName>05904063815371</tradeName>
    <deviceName>AQUANESIS E wanna do masażu podwodnego</deviceName>
    <manufacturerName>Biuro Handlowe Kinesis Andrzej Boruta</manufacturerName>
    <manufacturerSrn>PL-MF-000018445</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQUANESIS E</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:20.396Z</lastUpdated>
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    <udiDi>05903999609344</udiDi>
    <basicUdiDi>B-05903999609344</basicUdiDi>
    <tradeName>ergoLance</tradeName>
    <deviceName>Safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6870</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:19.586Z</lastUpdated>
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    <udiDi>05903999608408</udiDi>
    <basicUdiDi>B-05903999608408</basicUdiDi>
    <tradeName>MediSafe Solo</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9698</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:15.584Z</lastUpdated>
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    <udiDi>05903999607388</udiDi>
    <basicUdiDi>B-05903999607388</basicUdiDi>
    <tradeName>droplet</tradeName>
    <deviceName>Personal lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010402</emdnCode>
    <emdnDescription>LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9627</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:14.832Z</lastUpdated>
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    <udiDi>05903999605490</udiDi>
    <basicUdiDi>B-05903999605490</basicUdiDi>
    <tradeName>Single-let next</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9046</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:14.074Z</lastUpdated>
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    <udiDi>05903999605483</udiDi>
    <basicUdiDi>B-05903999605483</basicUdiDi>
    <tradeName>Single-let next</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9045</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:12.777Z</lastUpdated>
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    <udiDi>05903999605476</udiDi>
    <basicUdiDi>B-05903999605476</basicUdiDi>
    <tradeName>Single-let next</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:08.379Z</lastUpdated>
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    <udiDi>05903999605322</udiDi>
    <basicUdiDi>B-05903999605322</basicUdiDi>
    <tradeName>Medisafe Solo</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8899</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:07.580Z</lastUpdated>
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    <udiDi>05903999605292</udiDi>
    <basicUdiDi>B-05903999605292</basicUdiDi>
    <tradeName>Medisafe Solo</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:06.773Z</lastUpdated>
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    <udiDi>05903999605223</udiDi>
    <basicUdiDi>B-05903999605223</basicUdiDi>
    <tradeName>ergoLance</tradeName>
    <deviceName>safety lancet</deviceName>
    <manufacturerName>HTL-Strefa S.A.</manufacturerName>
    <manufacturerSrn>PL-MF-000002198</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V010401</emdnCode>
    <emdnDescription>LANCETS WITH SAFETY SYSTEMS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9196</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:07:05.983Z</lastUpdated>
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