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<eudamedExport entity="devices">
  <row>
    <udiDi>00810061910060</udiDi>
    <basicUdiDi>B-00810061910060</basicUdiDi>
    <tradeName>00810061910060</tradeName>
    <deviceName>Titanium, Castroviejo Cyclodialysis Spatula 0.75 mm</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST4-1140</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:36:16.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910053</udiDi>
    <basicUdiDi>B-00810061910053</basicUdiDi>
    <tradeName>00810061910053</tradeName>
    <deviceName>Titanium, Castroviejo Cyclodialysis Spatula 0.25 mm</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1705</emdnCode>
    <emdnDescription>OPHTHALMOLOGY PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST4-1130</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:36:16.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910046</udiDi>
    <basicUdiDi>B-00810061910046</basicUdiDi>
    <tradeName>00810061910046</tradeName>
    <deviceName>Titanium, Bechert Nucleus Rotator</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1711</emdnCode>
    <emdnDescription>OPHTHALMOLOGY HOOKS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST4-1070</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:36:12.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910039</udiDi>
    <basicUdiDi>B-00810061910039</basicUdiDi>
    <tradeName>00810061910039</tradeName>
    <deviceName>Titanium, Barraquer Iris Spatula, Smooth, Round</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1705</emdnCode>
    <emdnDescription>OPHTHALMOLOGY PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST4-1040</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:36:11.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910022</udiDi>
    <basicUdiDi>B-00810061910022</basicUdiDi>
    <tradeName>00810061910022</tradeName>
    <deviceName>Titanium, Thorton Fixation Ring</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1799</emdnCode>
    <emdnDescription>OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1-1211A</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:36:10.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910015</udiDi>
    <basicUdiDi>B-00810061910015</basicUdiDi>
    <tradeName>00810061910015</tradeName>
    <deviceName>Titanium, Liberman  Speculum K-Wire</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L170102</emdnCode>
    <emdnDescription>OCULAR AND ENDOCULAR RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST1-1026</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:36:09.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810059291584</udiDi>
    <basicUdiDi>B-00810059291584</basicUdiDi>
    <tradeName>00810059291584</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Denovo Dental Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047890</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L150799</emdnCode>
    <emdnDescription>ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:34:08.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810045538570</udiDi>
    <basicUdiDi>B-00810045538570</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor - Scoop Tip, 170mm, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00723</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:53.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810045534664</udiDi>
    <basicUdiDi>B-00810045534664</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tubular Retractor – Scoop Tip, 140mm, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1907</emdnCode>
    <emdnDescription>ARTHROSCOPIC SURGERY CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00721</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:33:52.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950074</udiDi>
    <basicUdiDi>B-00810008950074</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Cartridge</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050103</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASOUND SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-CT-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:56.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950067</udiDi>
    <basicUdiDi>B-00810008950067</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Catheter 3.5mm</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-063-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:52.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950050</udiDi>
    <basicUdiDi>B-00810008950050</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Connection Cable</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050103</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASOUND SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-CC-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:51.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950043</udiDi>
    <basicUdiDi>B-00810008950043</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Catheter 8mm</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-068-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:50.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950036</udiDi>
    <basicUdiDi>B-00810008950036</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Catheter 7mm</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-067-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:49.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950012</udiDi>
    <basicUdiDi>B-00810008950012</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName>Paradise Catheter 5mm</deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-065-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:45.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810008950005</udiDi>
    <basicUdiDi>B-00810008950005</basicUdiDi>
    <tradeName>Paradise™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ReCor Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027816</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K02050109</emdnCode>
    <emdnDescription>COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRDS-064-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:32.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729988</udiDi>
    <basicUdiDi>B-00810004729988</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Medium Ring Curette, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0901</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00584</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:31.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729810</udiDi>
    <basicUdiDi>B-00810004729810</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Small Ring Curette, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0901</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASY-00564</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:30.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729759</udiDi>
    <basicUdiDi>B-00810004729759</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Dilator 2, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01340</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:27.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810004729742</udiDi>
    <basicUdiDi>B-00810004729742</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Dilator 1, FH7 ENDO</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-00869</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:22:26.376Z</lastUpdated>
  </row>
</eudamedExport>