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    <tradeName>ENT treatment unit MODULA-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5100-30000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.862Z</lastUpdated>
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    <udiDi>04260548932003</udiDi>
    <basicUdiDi>0426054893MOD3K</basicUdiDi>
    <tradeName>ENT treatment unit MODULA Duo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0100-40000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.841Z</lastUpdated>
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    <udiDi>04260548932508</udiDi>
    <basicUdiDi>0426054893INC2S</basicUdiDi>
    <tradeName>Instrument module MODULA-ICL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5300-10100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.822Z</lastUpdated>
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    <udiDi>04260548932515</udiDi>
    <basicUdiDi>0426054893INC2S</basicUdiDi>
    <tradeName>Instrument module MODULA-HANSEAT L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0300-10100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.804Z</lastUpdated>
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    <udiDi>04260548932522</udiDi>
    <basicUdiDi>0426054893INC2S</basicUdiDi>
    <tradeName>Instrument module MODULA-HANSEAT XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0300-10000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.784Z</lastUpdated>
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  <row>
    <udiDi>04260548932539</udiDi>
    <basicUdiDi>0426054893INC2S</basicUdiDi>
    <tradeName>Instrument module MODULA-HANSEAT M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0300-20000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.766Z</lastUpdated>
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  <row>
    <udiDi>04260548933000</udiDi>
    <basicUdiDi>0426054893MOD3K</basicUdiDi>
    <tradeName>ENT treatment unit MODULA Paris</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0100-20000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.748Z</lastUpdated>
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    <udiDi>04260548933505</udiDi>
    <basicUdiDi>0426054893INC2S</basicUdiDi>
    <tradeName>Instrument module MODULA-ICM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5300-20000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.730Z</lastUpdated>
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  <row>
    <udiDi>04260548934007</udiDi>
    <basicUdiDi>0426054893MOD3K</basicUdiDi>
    <tradeName>ENT treatment unit MODULA Mini</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0100-10000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.713Z</lastUpdated>
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    <udiDi>04260548934502</udiDi>
    <basicUdiDi>0426054893MOD3K</basicUdiDi>
    <tradeName>ENT treatment unit MODULA-M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5100-10000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.695Z</lastUpdated>
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  <row>
    <udiDi>04260548935004</udiDi>
    <basicUdiDi>B-04260548935004</basicUdiDi>
    <tradeName>US 4000 (Ultrasound scanner)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.678Z</lastUpdated>
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  <row>
    <udiDi>04260548935509</udiDi>
    <basicUdiDi>B-04260548935509</basicUdiDi>
    <tradeName>Rhino 4000-M (Rhinomanometer)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RHINOMANOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.664Z</lastUpdated>
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  <row>
    <udiDi>04260548935516</udiDi>
    <basicUdiDi>B-04260548935516</basicUdiDi>
    <tradeName>Tymp 4000-M (Tympanometer)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260548935523</udiDi>
    <basicUdiDi>B-04260548935523</basicUdiDi>
    <tradeName>Combi 4000-M (a combination of tympanometry and rhinomanometry)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260548935530</udiDi>
    <basicUdiDi>B-04260548935530</basicUdiDi>
    <tradeName>Rhino 4000 (Rhinomanometer)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RHINOMANOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260548935547</udiDi>
    <basicUdiDi>B-04260548935547</basicUdiDi>
    <tradeName>Tymp 4000 (Tympanometer)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMPEDANCE METERS FOR THE AUDITORY SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260548935554</udiDi>
    <basicUdiDi>B-04260548935554</basicUdiDi>
    <tradeName>Combi 4000 (a combination of tympanometry and rhinomanometry)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.587Z</lastUpdated>
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  <row>
    <udiDi>04260548936506</udiDi>
    <basicUdiDi>B-04260548936506</basicUdiDi>
    <tradeName>ENG 4000 (Electronystagmograph)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VIDEO/ELECTRONYSTAGMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.570Z</lastUpdated>
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  <row>
    <udiDi>04260548936759</udiDi>
    <basicUdiDi>B-04260548936759</basicUdiDi>
    <tradeName>Air-Calorisator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OTO-CALORIC STIMULATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260548937008</udiDi>
    <basicUdiDi>B-04260548937008</basicUdiDi>
    <tradeName>TE-OAE 4000 (otoacoustic emission)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G. Heinemann Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000009705</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OTOACOUSTIC EMISSIONS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-1060</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T20:14:56.541Z</lastUpdated>
  </row>
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