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    <basicUdiDi>B-05059358038659</basicUdiDi>
    <tradeName>05059358038659</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED BALL GOLD, 70MM x 4.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-04031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:22.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038635</udiDi>
    <basicUdiDi>B-05059358038635</basicUdiDi>
    <tradeName>05059358038635</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED MATCH GOLD, 70MM X 3.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-03034</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:20.994Z</lastUpdated>
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  <row>
    <udiDi>05059358038611</udiDi>
    <basicUdiDi>B-05059358038611</basicUdiDi>
    <tradeName>05059358038611</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 3.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-03031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:20.193Z</lastUpdated>
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  <row>
    <udiDi>05059358038598</udiDi>
    <basicUdiDi>B-05059358038598</basicUdiDi>
    <tradeName>05059358038598</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED MATCH GOLD, 70MM X 2.2MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-02234</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:18.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038574</udiDi>
    <basicUdiDi>B-05059358038574</basicUdiDi>
    <tradeName>05059358038574</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED BALL GOLD, 70MM X 2.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-02031</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:16.195Z</lastUpdated>
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  <row>
    <udiDi>05059358038550</udiDi>
    <basicUdiDi>B-05059358038550</basicUdiDi>
    <tradeName>05059358038550</tradeName>
    <deviceName>BUR - 2.38MM, FLUTED MATCH GOLD, 70MM X 1.7MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-01734</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:14.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038123</udiDi>
    <basicUdiDi>B-05059358038123</basicUdiDi>
    <tradeName>05059358038123</tradeName>
    <deviceName>BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 6.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-06051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:13.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038109</udiDi>
    <basicUdiDi>B-05059358038109</basicUdiDi>
    <tradeName>05059358038109</tradeName>
    <deviceName>BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 5.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-05051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:12.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358038086</udiDi>
    <basicUdiDi>B-05059358038086</basicUdiDi>
    <tradeName>05059358038086</tradeName>
    <deviceName>BUR - 2.38MM, FINE DIAMOND BALL, 70MM X 4.0MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07-04051</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:09.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358036495</udiDi>
    <basicUdiDi>B-05059358036495</basicUdiDi>
    <tradeName>05059358036495</tradeName>
    <deviceName>BUR - 3.18MM, X COARSE DIAMOND CYL, 140MM X 6.5MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D14-06582</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:08.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358036471</udiDi>
    <basicUdiDi>B-05059358036471</basicUdiDi>
    <tradeName>05059358036471</tradeName>
    <deviceName>BUR - 3.18MM, X COARSE DIAMOND CYL, 90MM X 6.5MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D09-06582</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:07.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358036457</udiDi>
    <basicUdiDi>B-05059358036457</basicUdiDi>
    <tradeName>05059358036457</tradeName>
    <deviceName>BUR - 2.38MM, X COARSE DIAMOND CYL, 150MM X 6.5MM</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100985</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C15-06582</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T14:30:05.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>05059358034453</udiDi>
    <basicUdiDi>50605201INT02MAN07WE</basicUdiDi>
    <tradeName>05059358034453</tradeName>
    <deviceName>Foot control pedals used in combination with surgical power tools to ream, bur, drill and cut bone</deviceName>
    <manufacturerName>Zethon Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000014309</manufacturerSrn>
    <authorisedRepresentativeName>De Soutter Medical Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-270</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:41:00.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>04046963519209</udiDi>
    <basicUdiDi>40392390000026763C</basicUdiDi>
    <tradeName>HI-LINE XS</tradeName>
    <deviceName>PS-Tools rotating instr. diamond SU</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE286SU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:50:52.055Z</lastUpdated>
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  <row>
    <udiDi>04046963417482</udiDi>
    <basicUdiDi>40392390000026753A</basicUdiDi>
    <tradeName>HI-LINE XS</tradeName>
    <deviceName>PS-Tools rotating instrument sterile SU</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE549SU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:50:44.838Z</lastUpdated>
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  <row>
    <udiDi>04046955799336</udiDi>
    <basicUdiDi>403923900000281634</basicUdiDi>
    <tradeName>ELAN 4</tradeName>
    <deviceName>2.35 rotating instrument</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE851R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:50:33.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653458110</udiDi>
    <basicUdiDi>40392390000026683D</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName>PS-Tools bone rasp</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC623R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:48:19.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653339785</udiDi>
    <basicUdiDi>403923900000267438</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName>PS-Tools saw blade SU</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC615R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:55.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653339273</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName>PS-Tools saw blade sterile RU</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD390R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:50.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653075447</udiDi>
    <basicUdiDi>40392390000026702Y</basicUdiDi>
    <tradeName>HI-LINE</tradeName>
    <deviceName>PS-Tools rotating instr. diamond RU</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD787R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:15.036Z</lastUpdated>
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