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    <tradeName>Swoop® Portable MR Imaging® System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-11001-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.933Z</lastUpdated>
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    <udiDi>00850043319023</udiDi>
    <basicUdiDi>0860000606100001R3</basicUdiDi>
    <tradeName>Swoop Transmit and Receive Radio Frequency Head Coil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>815-11016-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.916Z</lastUpdated>
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    <udiDi>00850043319030</udiDi>
    <basicUdiDi>0860000606100002R5</basicUdiDi>
    <tradeName>00850043319030</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>810-11113-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.898Z</lastUpdated>
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    <basicUdiDi>0850043319900110210026</basicUdiDi>
    <tradeName>00850043319047</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-11021-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.880Z</lastUpdated>
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    <udiDi>00850043319146</udiDi>
    <basicUdiDi>085004331990011022002B</basicUdiDi>
    <tradeName>00850043319146</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-11022-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.863Z</lastUpdated>
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    <udiDi>00850043319153</udiDi>
    <basicUdiDi>0860000606100002R5</basicUdiDi>
    <tradeName>00850043319153</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PATIENT POSITIONING MEDICAL CUSHIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>204-00081-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.847Z</lastUpdated>
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  <row>
    <udiDi>00850043319160</udiDi>
    <basicUdiDi>0860000606100001R3</basicUdiDi>
    <tradeName>Swoop Portable MR Imaging System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>850-11010-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.830Z</lastUpdated>
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  <row>
    <udiDi>00850043319184</udiDi>
    <basicUdiDi>0860000606100001R3</basicUdiDi>
    <tradeName>Swoop Transmit and Receive Radio Frequency Head Coil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>815-11148-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:44:23.812Z</lastUpdated>
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    <udiDi>00860000606134</udiDi>
    <basicUdiDi>0860000606100003R7</basicUdiDi>
    <tradeName>00860000606134</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hyperfine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029806</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>810-11049-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:56.334Z</lastUpdated>
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