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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8227] QC Sets and Panels: Helix Elite™ C. difficile Control Panel (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:09.164Z</lastUpdated>
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    <udiDi>70845357042704</udiDi>
    <basicUdiDi>084535708231AZ</basicUdiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8231] QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:08.366Z</lastUpdated>
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    <udiDi>70845357042698</udiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080805</emdnCode>
    <emdnDescription>PARASITOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8230] QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:07.565Z</lastUpdated>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8228] QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:06.759Z</lastUpdated>
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    <udiDi>70845357041493</udiDi>
    <basicUdiDi>084535708219BB</basicUdiDi>
    <tradeName>70845357041493</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8219] QC Sets and Panels: Helix Elite™ Group A Streptococcus (GAS) Control Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:02.760Z</lastUpdated>
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    <udiDi>70845357041448</udiDi>
    <basicUdiDi>084535708184BH</basicUdiDi>
    <tradeName>70845357041448</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8184] QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:01.975Z</lastUpdated>
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    <udiDi>70845357041431</udiDi>
    <basicUdiDi>084535708181BB</basicUdiDi>
    <tradeName>70845357041431</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8181] QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:01.164Z</lastUpdated>
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    <udiDi>70845357041424</udiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8180] QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:56:00.374Z</lastUpdated>
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    <udiDi>70845357041400</udiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8205] QC Sets and Panels: Helix Elite™ Norovirus Control Panel (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:55.564Z</lastUpdated>
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    <udiDi>70845357041387</udiDi>
    <basicUdiDi>084535708203AU</basicUdiDi>
    <tradeName>70845357041387</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8203] QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:54.751Z</lastUpdated>
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    <udiDi>70845357041363</udiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8191] QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:53.954Z</lastUpdated>
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    <udiDi>70845357041325</udiDi>
    <basicUdiDi>084535708209B8</basicUdiDi>
    <tradeName>70845357041325</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8209] QC Sets and Panels: Helix Elite™ Vaginal Control Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:53.157Z</lastUpdated>
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    <udiDi>70845357041318</udiDi>
    <basicUdiDi>084535708208B6</basicUdiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8208] QC Sets and Panels: Helix Elite™ Vaginal Verification Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:49.188Z</lastUpdated>
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    <udiDi>70845357041202</udiDi>
    <basicUdiDi>084535708190BC</basicUdiDi>
    <tradeName>70845357041202</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8190] QC Sets and Panels: Helix Elite™ Enterovirus (EV) Control Panel (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:48.363Z</lastUpdated>
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    <udiDi>70845357041196</udiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8189] QC Sets and Panels: Helix Elite™ Trichomonas vaginalis (TV) Control Panel (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:47.563Z</lastUpdated>
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    <udiDi>70845357041172</udiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080801</emdnCode>
    <emdnDescription>BACTERIOLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8187] QC Sets and Panels: Helix Elite™ Carbapenem-resistant Enterobacteriaceae (CRE) Control Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:46.760Z</lastUpdated>
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    <udiDi>70845357041158</udiDi>
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    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8211] QC Sets and Panels: Helix Elite™ Enteric Viral Control Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:41.953Z</lastUpdated>
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    <tradeName>70845357041141</tradeName>
    <deviceName>QC Sets and Panels: Helix Elite™</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[8210] QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:55:38.755Z</lastUpdated>
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    <udiDi>10845357043594</udiDi>
    <basicUdiDi>08453570HE0067NS37</basicUdiDi>
    <tradeName>10845357043594</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0067NS] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Swab)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:53.758Z</lastUpdated>
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    <tradeName>10845357043273</tradeName>
    <deviceName>Helix Elite™ Molecular Standards: Inactivated Standard</deviceName>
    <manufacturerName>Microbiologics, INC.</manufacturerName>
    <manufacturerSrn>US-MF-000000466</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>[HE0058N] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:53:48.145Z</lastUpdated>
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