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    <tradeName>POWERFLEX SINGLE USE FIBER DELIVERY DEVICE</tradeName>
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    <manufacturerName>Luvo Medical Technologies Inc.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <lastUpdated>2026-07-04T15:31:04.456Z</lastUpdated>
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    <tradeName>POWERFLEX SINGLE USE FIBER DELIVERY DEVICE</tradeName>
    <deviceName>POWERFLEX SINGLE USE FIBER DELIVERY DEVICE</deviceName>
    <manufacturerName>Luvo Medical Technologies Inc.</manufacturerName>
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    <tradeName>POWERFLEX SINGLE USE FIBER DELIVERY DEVICE</tradeName>
    <deviceName>POWERFLEX SINGLE USE FIBER DELIVERY DEVICE</deviceName>
    <manufacturerName>Luvo Medical Technologies Inc.</manufacturerName>
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    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:02.055Z</lastUpdated>
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    <tradeName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</tradeName>
    <deviceName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</deviceName>
    <manufacturerName>Luvo Medical Technologies Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028601</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1000R</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:31:00.455Z</lastUpdated>
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    <udiDi>00754015200039</udiDi>
    <basicUdiDi>B-00754015200039</basicUdiDi>
    <tradeName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</tradeName>
    <deviceName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</deviceName>
    <manufacturerName>Luvo Medical Technologies Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028601</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>550R</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:58.055Z</lastUpdated>
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    <udiDi>00754015200022</udiDi>
    <basicUdiDi>B-00754015200022</basicUdiDi>
    <tradeName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</tradeName>
    <deviceName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</deviceName>
    <manufacturerName>Luvo Medical Technologies Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028601</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>365R</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:56.451Z</lastUpdated>
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    <tradeName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</tradeName>
    <deviceName>POWERFLEX REUSABLE FIBER DELIVERY DEVICE</deviceName>
    <manufacturerName>Luvo Medical Technologies Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028601</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:30:55.654Z</lastUpdated>
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    <basicUdiDi>B-00647529003961</basicUdiDi>
    <tradeName>Laser Handpiece</tradeName>
    <deviceName>Turbo Handpiece</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6201126</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:44:59.286Z</lastUpdated>
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    <basicUdiDi>B-00647529003824</basicUdiDi>
    <tradeName>Laser Handpiece</tradeName>
    <deviceName>Deep Tissue Handpiece</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6400311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:44:24.017Z</lastUpdated>
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    <udiDi>00647529003800</udiDi>
    <basicUdiDi>B-00647529003800</basicUdiDi>
    <tradeName>Waterlase Laser Tips - Sapphire</tradeName>
    <deviceName>WL Laser Tips, Starter Kit, 5PK</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7230001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:44:19.209Z</lastUpdated>
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    <udiDi>00647529003725</udiDi>
    <basicUdiDi>B-00647529003725</basicUdiDi>
    <tradeName>Laser Handpiece</tradeName>
    <deviceName>Whitening Handpiece</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7400022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:44:18.413Z</lastUpdated>
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    <basicUdiDi>B-00647529003718</basicUdiDi>
    <tradeName>Laser Handpiece</tradeName>
    <deviceName>Gold Straight Handpiece</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7220003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:44:17.610Z</lastUpdated>
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    <tradeName>Diode Laser Tips - Non Initiated Tips</tradeName>
    <deviceName>Diode Laser Tips, ezTips, Surgical, E4100/E4-250, 2PK</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011099</emdnCode>
    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7400053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:44:12.808Z</lastUpdated>
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    <basicUdiDi>B-00647529003633</basicUdiDi>
    <tradeName>Laser Handpiece</tradeName>
    <deviceName>Fractional Handpiece</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Waterlase Laser Tips - Sapphire</tradeName>
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    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
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    <tradeName>Waterlase Laser Tips - Sapphire</tradeName>
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    <manufacturerName>BIOLASE MG LLC</manufacturerName>
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    <tradeName>Waterlase Laser Tips - Sapphire</tradeName>
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    <manufacturerName>BIOLASE MG LLC</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <tradeName>Waterlase Laser Tips - Sapphire</tradeName>
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    <manufacturerName>BIOLASE MG LLC</manufacturerName>
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    <tradeName>Diode Laser Tips - Pre Initiated Tips</tradeName>
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    <manufacturerName>BIOLASE MG LLC</manufacturerName>
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    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Diode Laser Tips - Pre Initiated Tips</tradeName>
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    <manufacturerName>BIOLASE MG LLC</manufacturerName>
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    <emdnDescription>LASER SURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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