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    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>GEL-E DONUT, MEDIUM (CASE OF 12)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803196391</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.945Z</lastUpdated>
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    <udiDi>00850018561044</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Gel-E Donut, Extra Small, 12/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803196371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.925Z</lastUpdated>
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    <udiDi>00850018561051</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Gel-E Donut, Small, 12/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803196381</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.902Z</lastUpdated>
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    <udiDi>00850018561068</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>SQUISHON 2, GEL PILLOW (CASE OF 12)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989803196361</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.879Z</lastUpdated>
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    <udiDi>00850018561075</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>SQUISHON MATTRESS, 1/CS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805603301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.856Z</lastUpdated>
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    <udiDi>00850018561082</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>SQUISHON 3, GEL PILLOW, 12/CASE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805606461</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.835Z</lastUpdated>
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    <udiDi>00850018561099</udiDi>
    <basicUdiDi>0850018561Therapy1B2</basicUdiDi>
    <tradeName>Wee Sight Transilluminator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRANSILLUMINATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805603761</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.815Z</lastUpdated>
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    <udiDi>00850018561105</udiDi>
    <basicUdiDi>0850018561JAUNDICEMR</basicUdiDi>
    <tradeName>WeeSpecs, Small (28-34 cm), 50/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805607641</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.796Z</lastUpdated>
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    <udiDi>00850018561136</udiDi>
    <basicUdiDi>0850018561JAUNDICEMR</basicUdiDi>
    <tradeName>WEESPECS SUPREME - SMALL, 50/CASE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805604161</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.776Z</lastUpdated>
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  <row>
    <udiDi>00850018561143</udiDi>
    <basicUdiDi>0850018561JAUNDICEMR</basicUdiDi>
    <tradeName>WeeSpecs Supreme, Medium, 50/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805604161</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.757Z</lastUpdated>
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  <row>
    <udiDi>00850018561150</udiDi>
    <basicUdiDi>0850018561JAUNDICEMR</basicUdiDi>
    <tradeName>WEESPECS,PREEMIE LESS THAN 28CM, 50/CS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805607631</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.738Z</lastUpdated>
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  <row>
    <udiDi>00850018561167</udiDi>
    <basicUdiDi>0850018561JAUNDICEMR</basicUdiDi>
    <tradeName>WeeSpecs, Medium (&gt;34 cm), 50/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805607651</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.720Z</lastUpdated>
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    <udiDi>00850018561174</udiDi>
    <basicUdiDi>0850018561JAUNDICEMR</basicUdiDi>
    <tradeName>WEESPECS SUPREME - PREEMIE, 50/CASE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHOTOTHERAPY MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805604201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.699Z</lastUpdated>
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  <row>
    <udiDi>00850018561211</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Frederick T. Frog Positioning Aid, Resuable - Washable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805603341</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.673Z</lastUpdated>
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    <udiDi>00850018561228</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Frederick T. Frog Positoning Aid, Reusable - Wipeable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805635141</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.649Z</lastUpdated>
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    <udiDi>00850018561242</udiDi>
    <basicUdiDi>0850018561NxtGenAccT8RG</basicUdiDi>
    <tradeName>Patient Skin Temperature Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BODY TEMPERATURE MONITORING PROBES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>739-1603</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.624Z</lastUpdated>
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    <udiDi>00850018561334</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Snuggleup, Reusable, Medium,  12/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805606291</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.604Z</lastUpdated>
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    <udiDi>00850018561341</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Snuggleup, Reusable, Small, 12/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805606281</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.583Z</lastUpdated>
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    <udiDi>00850018561358</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Snuggleup, Disposable, Medium,  12/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805607401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.558Z</lastUpdated>
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    <udiDi>00850018561365</udiDi>
    <basicUdiDi>0850018561POSITION3H</basicUdiDi>
    <tradeName>Snuggleup, Disposable, Small,  12/pk</tradeName>
    <deviceName></deviceName>
    <manufacturerName>International Biomedical</manufacturerName>
    <manufacturerSrn>US-MF-000017330</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEWBORN POSITIONERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989805607391</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:35.545Z</lastUpdated>
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