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    <deviceName>Pulsed Er-YAG Laser</deviceName>
    <manufacturerName>Lutronic Corporation</manufacturerName>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-10T21:56:52.815Z</lastUpdated>
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    <manufacturerName>Laseroptek</manufacturerName>
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    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LOTUS III</reference>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, pearl white</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-04T14:45:20.900Z</lastUpdated>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, rose gold</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-217</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:20.098Z</lastUpdated>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, jungle</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:19.295Z</lastUpdated>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, aquarium</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:18.493Z</lastUpdated>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, yellow</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:14.494Z</lastUpdated>
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    <basicUdiDi>B-00647529004418</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, purple</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:13.698Z</lastUpdated>
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    <basicUdiDi>B-00647529004401</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, platinum</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:12.893Z</lastUpdated>
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    <udiDi>00647529004395</udiDi>
    <basicUdiDi>B-00647529004395</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, burnt orange</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:12.095Z</lastUpdated>
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    <udiDi>00647529004388</udiDi>
    <basicUdiDi>B-00647529004388</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, bright lime</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:08.093Z</lastUpdated>
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    <udiDi>00647529004371</udiDi>
    <basicUdiDi>B-00647529004371</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, midnight blue</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:07.294Z</lastUpdated>
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    <udiDi>00647529004364</udiDi>
    <basicUdiDi>B-00647529004364</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, gloss black</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 IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-203</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:06.495Z</lastUpdated>
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    <udiDi>00647529004340</udiDi>
    <basicUdiDi>B-00647529004340</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, rose gold</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>Z12011014</emdnCode>
    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:01.682Z</lastUpdated>
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    <udiDi>00647529004128</udiDi>
    <basicUdiDi>B-00647529004128</basicUdiDi>
    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, premier, racing red</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>ERBIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:45:00.884Z</lastUpdated>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, zebra</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, fish</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-15</reference>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, jungle</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>7200854-14</reference>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, aquarium</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
    <manufacturerSrn>US-MF-000028587</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Waterlase iPlus Laser System</tradeName>
    <deviceName>Waterlase iPlus YSGG all tissue dental laser system, yellow</deviceName>
    <manufacturerName>BIOLASE MG LLC</manufacturerName>
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