Regulatory documentation
Documents of type Declaration Of Conformity in MDR category:
Product Sort descending | Changed | Document |
---|---|---|
Amika | 2023/04/10 | |
Agilia VP MC WiFi | 2022/04/11 | |
Agilia VP MC WiFi | 2024/02/14 | |
Agilia SP MC WiFi | 2024/02/14 | |
Conox | 2024/04/22 | |
Conox | 2024/02/22 | |
Amika+ | 2023/04/10 | |
Agilia Partner | 2024/04/26 | |
Agilia Partner | 2022/04/11 | |
Agilia SP | 2024/02/14 | |
Agilia SP | 2022/05/16 | |
Agilia VP | 2022/04/11 | |
Agilia VP | 2024/02/14 | |
Agilia Accessories | 2024/02/14 | |
Agilia Accessories | 2024/02/22 | |
Agilia SP TIVA WiFi | 2024/02/14 | |
Agilia SP TIVA WiFi | 2022/05/16 | |
Agilia SP PCA WiFi | 2024/02/14 | |
Agilia SP PCA WiFi | 2024/02/14 | |
Vigilant Software Suite | 2022/04/07 | |
INfusia SP7s | 2023/05/11 | |
2023/05/11 | ||
INfusia VP7s | 2023/05/11 | |
Exelia Partner | 2023/07/21 | |
Exelia Partner | 2023/09/13 | |
Exelia SP | 2023/07/20 | |
Exelia VP | 2023/07/21 | |
Exelia Link | 2023/07/21 | |
Exelia Combox | 2023/07/21 | |
Exelia Combox | 2023/07/21 | |
Exelia DuoLink | 2023/07/21 | |
Exelia Therapy Manager | 2023/07/21 | |
Exelia Therapy Manager | 2023/07/21 | |
Exelia Therapy Manager | 2023/07/21 | |
Agilia Link | 2022/04/11 | |
Link+ Agilia | 2024/02/14 | |
Amika & Ambix nova Partner | 2023/10/26 | |
Ambix nova | 2023/06/14 | |
Ambix nova | 2023/06/26 | |
Ambix nova | 2023/05/11 | |
Ambix NONCORstick Safe 19G x 17 mm | 2024/03/22 | |
Ambix NONCORstick Safe 20G x 20 mm | 2024/03/22 | |
Ambix NONCORstick Safe 19G x 27 mm | 2024/03/22 | |
Ambix NONCORstick Safe 22G x 14 mm | 2024/03/22 | |
Ambix NONCORstick Safe 22G x 27 mm | 2024/03/22 | |
Ambix NONCORstick Safe 20G x 14 mm | 2024/03/22 | |
Ambix NONCORstick Safe 20G x 17 mm | 2024/03/22 | |
Ambix NONCORstick Safe 22G x 17 mm | 2024/03/22 | |
Ambix activ set ambulatory | 2023/06/14 | |
Ambix NONCORstick Safe 22G x 20 mm | 2024/03/22 | |
Ambix NONCORstick Safe, 20G x 10 mm | 2024/03/22 | |
Ambix NONCORstick Safe 19G x 35 mm | 2024/03/22 | |
Ambix activ Set stationary | 2023/06/14 | |
Ambix NONCORstick Safe 20G x 35 mm | 2024/03/22 | |
Ambix NONCORstick Safe 22G x 35 mm | 2024/03/22 | |
Amika Pump Set Varioline Comfort, ENFit | 2024/03/27 | |
Amika Pump Set Varioline, ENFit | 2024/03/27 | |
GraviSet Varioline, ENFit | 2024/03/27 | |
Amika Pump Set TwoLine EasyBag, ENFit | 2024/03/27 | |
Amika Pump Set Bag mobile, ENFit | 2024/03/27 | |
Amika Pump Set EasyBag, universal, ENFit | 2024/03/27 | |
Amika Pump Set EasyBag mobile, ENFit | 2024/03/27 | |
GraviSet Bag, ENFit | 2024/03/27 | |
Amika Bag mobile with cover, ENFit | 2024/03/27 | |
Ambix Intrastick Safe, 19G X 14 mm - 8081211 | 2024/03/22 | |
Ambix Intrastick Safe, 19G X 17 mm | 2024/03/22 | |
Ambix Intrastick Safe, 19G X 20 mm | 2024/03/22 | |
Ambix Intrastick Safe, 19G X 27 mm | 2024/03/22 | |
Ambix Intrastick Safe, 20G X 14 mm - 8081261 | 2024/03/22 | |
Ambix Intrastick Safe, 20G X 17 mm - 8081271 | 2024/03/22 | |
Ambix Intrastick Safe, 20G X 20 mm - 8081281 | 2024/03/22 | |
Ambix Intrastick Safe, 20G X 27 mm | 2024/03/22 | |
Ambix Intrastick Safe, 22G X 14 mm - 8081301 | 2024/03/22 | |
Ambix Intrastick Safe, 22G X 17 mm - 8081311 | 2024/03/22 | |
Ambix Intrastick Safe, 22G X 20 mm | 2024/03/22 | |
Ambix Intrastick Safe, 22G X 27 mm | 2024/03/22 | |
Amika Bag, ENFit | 2024/03/27 | |
GraviSet EasyBag with cover, ENFit | 2024/03/27 | |
Applix Smart/Vision Bag, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set TwoLine EasyBag, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set EasyBag mobile, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision Varioline, ENFit | 2024/03/27 | |
Amika Bag with cover, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set EasyBag, universal, ENFit | 2024/03/27 | |
GraviSet EasyBag, universal, ENFit | 2024/03/27 | |
Amika Pump Set Varioline, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision TwoLine EasyBag, ENFit | 2024/03/27 | |
Amika EasyBag mobile with cover, ENFit | 2024/03/27 | |
Amika Pump Set TwoLine Easybag, universal, ENFit | 2024/03/27 | |
Amika Pump Set EasyBag, universal, ENFit, UK | 2024/03/27 | |
Applix Smart/Vision EasyBag with cover, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set EasyBag with cover, universal, ENFit | 2024/03/27 | |
GraviSet Varioline, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision EasyBag mobile, ENFit | 2024/03/27 | |
Amika EasyBag with cover, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set Varioline, universal, ENFit | 2024/03/27 | |
GraviSet EasyBag with cover, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision Bag mobile, ENFit | 2024/03/27 | |
Amika EasyBag non med port with cover, ENFit | 2024/03/27 | |
GraviSet Bag, universal, ENFit | 2024/03/27 | |
Amika Pump Set Varioline Comfort, universal, ENFit | 2024/03/27 | |
Amika Pump Set EasyBag mobile, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision EasyBag, ENFit | 2024/03/27 | |
Amika Varioline with cover, ENFit | 2024/03/27 | |
Amika Pump Set Bag mobile, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set Bag, universal, ENFit | 2024/03/27 | |
Amika Pump Set Bag, universal, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set Bag mobile, universal, ENFit | 2024/03/27 | |
Freka Mix Mischbeutel 1000 ml + 3-fach Transferset, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 1000 ml, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 2000 ml, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 3000 ml, DEHP-frei | 2024/03/25 | |
Freka Mix-Mischbeutel 150 ml, DEHP-frei | 2024/03/25 | |
Freka Mix-Mischbeutel 250 ml, DEHP-frei | 2024/03/25 | |
Freka Mix-Mischbeutel 500 ml, DEHP-frei | 2024/03/25 | |
3-filling leads | 2024/03/25 | |
Freka Mix Mischbeutel 3000 ml + 3-fach Transferset, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 2000 ml + 3-fach Transferset, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 250 ml, TP, LL, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 500 ml, TP, LL, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 3000 ml + 6-fach Transferset, Filter, DEHP-frei | 2024/03/25 | |
Multilayer Freka Mix 3000ml, TP + 6-fach Transferset, Filter, DEHP-frei | 2024/03/25 | |
Multilayer Freka Mix 4000ml, TP + 6-fach Transferset, Filter, DEHP-frei | 2024/03/25 | |
Freka Mix Mischbeutel 2000 ml + 6 -fach Transferset, DEHP-frei | 2024/03/25 | |
1-filling leads 100 cm | 2024/03/25 | |
Amika TwoLine EasyBag with cover, ENFit | 2024/03/27 | |
MS 10 DEHP-FREE | 2024/03/25 | |
Ambix NONCORstick Safe 19G x 14 mm | 2024/03/22 | |
Ambix NONCORstick Safe 20G x 27 mm | 2024/03/22 | |
Ambix NONCORstick Safe 19G x 20 mm | 2024/03/22 | |
GraviSet EasyBag, ENFit | 2024/03/27 | |
Applix Smart/Vision Pump Set Varioline Comfort, universal, ENFit | 2024/03/27 | |
Infusion Set VL SP 90 | 2024/03/25 | |
Freka® Repair Set for Freka® PEG FR 15, ENFit | 2024/04/15 | |
Infusion Set VL ST 00 | 2024/03/25 | |
Infusion Set VL ST 10 | 2024/03/25 | |
Freka® Repair Set for Freka® PEG FR 20, ENFit | 2024/04/15 | |
Freka® Connector for Freka® PEG FR 15, ENFit | 2024/04/15 | |
Freka® Connector for Freka® PEG FR 20, ENFit | 2024/04/15 | |
Freka® Tube Clamp for Freka® PEG CH/FR 9 and CH/FR 15 | 2024/04/15 | |
Freka® Fixation Plate for Freka® PEG FR 20 | 2024/04/15 | |
Freka® Fixation Plate for Freka® PEG FR 9 | 2024/04/15 | |
Freka® GastroTube FR15, ENFit | 2024/03/27 |
602_TF Percutaneous Tubes Replacement Sets and Accessories_IIb_EU DoC_NEN60212b_7755648_26.03.2024
|
Applix Smart/Vision Varioline Comfort, ENFit | 2024/03/27 | |
Freka® Fixation Plate for Freka® PEG FR 15 | 2024/04/15 | |
Freka® Y-Connector for Freka® PEG FR 15/9, ENFit | 2024/04/15 | |
Freka® Y-Connector for Freka® PEG FR 20/12, ENFit | 2024/04/15 | |
Insert for Freka® GastroTube FR 15, ENFit | 2024/04/15 | |
Freka® Universal Funnel Adaptor, ENFit | 2024/04/15 | |
Freka® Adaptor LL-ENFit | 2024/04/15 | |
Freka® Connect Adaptor ENFit-LL | 2024/04/15 | |
Freka® ENFit/ENLock Step Adaptor | 2024/04/15 | |
Freka® MediAdaptor ENFit-LL | 2024/04/15 | |
Freka® Tape for Tube Fixation | 2024/04/15 | |
ProNeo Plaster | 2024/04/15 | |
Applix VarioLine Adaptor ENPlus | 2024/03/27 | |
Exelia ComCable 10m | 2023/07/21 | |
TM support | 2023/07/21 | |
Smart Holder COM EU Accessory - CS1000429 | 2023/05/11 | |
Ambix Intrastick Safe, 20G X 10 mm | 2024/03/22 | |
Smart Holder Power EU Accessory - CS1000428 | 2023/05/11 | |
Amika AC adapter/charger - Z044904 (EU) | 2023/05/11 | |
Amika AC adapter/charger - Z044907 | 2023/05/11 | |
Freka® Connector for Freka® PEG FR 9, ENFit - 7981385 | 2024/04/15 | |
Freka® Repair Set for Freka® PEG FR 9, ENFit - 7981382 | 2024/04/15 | |
Freka® Repair Set for Freka® FCJ, ENFit - 7981388 | 2024/04/15 | |
Freka® Click Adaptor FR 9 for PEG FR 15, ENFit - 7981389 | 2024/04/15 | |
Freka® Click Adaptor FR 12 for PEG FR 20, ENFit - 7981390 | 2024/04/15 | |
Freka® Cap ENFit / ProNeo - 7981403 | 2024/04/15 | |
Amika Pump Set Bag, universal, ENFit, UK - 7751715T | 2024/03/27 | |
Amika EasyBag, ENFit - 7751900 | 2024/03/27 | |
Applix Smart/Vision EasyBag non med port with cover, ENFit - 7751930 | 2024/03/27 | |
Applix Smart/Vision Varioline with cover, ENFit - 7751932 | 2024/03/27 | |
Applix Smart/Vision Bag with cover, ENFit - 7751933 | 2024/03/27 | |
Applix Smart/Vision Bag mobile with cover, ENFit - 7751934 | 2024/03/27 | |
Applix Smart/Vision TwoLine EasyBag with cover, ENFit - 7751935 | 2024/03/27 | |
Applix Smart/Vision EasyBag mobile with cover, ENFit - 7751996 | 2024/03/27 | |
Ambix Safe-Can 20G 25 mm 90 ° - 5036761 | 2024/03/22 | |
Ambix Safe-Can 20G 37 mm 90° - 5036771 | 2024/03/22 | |
Ambix Safe-Can 22G 25 mm 90° - 5036781 | 2024/03/22 | |
Ambix Safe-Can 22G 37 mm 90° - 5036791 | 2024/03/22 | |
Ambix Safe-Can 22G 60 mm - 5036801 | 2024/03/22 | |
Ambix Safe-Can 22G 25 mm - 5036711 | 2024/03/22 | |
Ambix Safe-Can 22G 37 mm - 5036721 | 2024/03/22 | |
Ambix Safe-Can 20G 37 mm - 5036741 | 2024/03/22 | |
Freeflex+ Transfer Adapter | 2023/11/30 | |
Freka® Stoma Measuring Device | 2024/03/27 |
602_TF Percutaneous Tubes Replacement Sets and Accessories_Is_EU DoC_NEN60221s_27Mar2024
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Freka Lipoflow | 2023/11/30 | |
Infusion Set VL PR 42-11 (NAM) | 2024/03/25 | |
Infusion Set VL PR 72-11 (NAM) | 2024/03/25 | |
Infusion Set VL PR 42-12 (NAM) | 2024/03/25 | |
Infusion Set VL SP91-PE | 2024/03/25 | |
Infusion Set VL PN93 | 2024/03/25 | |
Infusion Set VL ST00 AirBlock | 2024/03/25 | |
Infusion Set VL ST01 AirBlock | 2024/03/25 | |
Infusion Set VL ST10 AirBlock | 2024/03/25 | |
Infusion Set VL ST02 | 2024/03/25 | |
Infusion Set VL ST02-ND | 2024/03/25 | |
Infusion Set VL ST22 | 2024/03/25 | |
Infusion Set VL ST42 | 2024/03/25 | |
VL TR12 Transfusion | 2024/03/19 | |
VL TR22 Transfusion | 2024/03/19 | |
VL SP22 2 Spikes | 2024/03/19 | |
Infusion Set VL SP62 - M46443400Y | 2024/03/25 | |
Infusion Set VL SP92 | 2024/03/25 | |
Infusion Set VL ON11 | 2024/03/25 | |
Infusion Set VL ON42 | 2024/03/25 | |
Infusion Set VL ON401 | 2024/03/25 | |
Infusion Set VL ON42 OP NF | 2024/03/25 | |
Infusion Set VL ON72 | 2024/03/25 | |
Infusion Set VL ON22 OP NF | 2024/03/25 | |
Infusion Set VL PN02 | 2024/03/25 | |
Infusion Set VL ON91 | 2024/03/25 | |
Infusion Set VL PA92 | 2024/03/25 | |
Infusion Set VL ON42 OP | 2024/03/25 | |
Infusion Set VL ON22 OP - M46446000Y | 2024/03/25 | |
Secondary Line SL OP IP Light‐protected, PUR material | 2024/03/19 | |
Secondary Line SL IP PUR material | 2024/03/19 | |
Secondary Line SL Filter IP PUR material | 2024/03/19 | |
K-Zero IV Needleless Connector - M79400849Y | 2024/03/25 | |
Infusion Set MS31 DEHP-free | 2024/03/25 | |
Infusion Set VL PA02 | 2024/03/25 | |
VL TR42 Transfusion | 2024/03/19 | |
Infusion Set VL ST44 | 2024/03/25 | |
Infusion Set VL PA93 | 2024/03/25 | |
Infusion Set VL ON42 FX | 2024/03/25 | |
Infusion Set VL ON42 SC | 2024/03/25 | |
Infusion Set VL ON42 OP SC | 2024/03/25 | |
Infusion Set VL ON42 OP NF - M46444085Y | 2024/03/25 | |
Infusion Set VL ON22 | 2024/03/25 | |
Infusion Set VL ON22 OP NF - M46444235Y | 2024/03/25 | |
Infusion Set VL ON22 FX | 2024/03/25 | |
VL TR43 Transfusion | 2024/03/19 | |
Infusion Set VL ON21 | 2024/03/25 | |
Infusion Set VL ON12 | 2024/03/25 | |
Infusion Set VL ON12 FX | 2024/03/25 | |
Infusion Set VL PA94 | 2024/03/25 | |
VL TR21 Transfusion | 2024/03/19 | |
K-Zero Extension | 2024/03/19 | |
Infusion Set VL SP91-PE - M46444904Y | 2024/03/25 | |
Infusion Set VL ST02 AirBlock - M46441920Y | 2024/03/25 | |
Infusion Set VL ST22 AirBlock - M46442520Y | 2024/03/25 | |
Infusion Set VL ST42 AirBlock - M46442620Y | 2024/03/25 | |
Infusion Set VL ON17 | 2024/03/25 | |
Injectomat® Syringe 50 ml with cannula 1.8 mm x 38 mm | 2024/02/19 | |
Injectomat® Syringe 50 ml | 2024/02/19 | |
Injectomat® Syringe 50 ml, light protected with cannula 1.8 mm x 38 mm | 2024/02/19 | |
Infusion Set VL SP90 AirBlock | 2024/03/25 | |
Infusion Set VL ON42 OP NF AirBlock | 2024/03/25 | |
Infusion Set VL ON22 AirBlock | 2024/03/25 | |
Infusion Set VL ON22 OP NF AirBlock | 2024/03/25 | |
Infusion Set VL PN00 AirBlock | 2024/03/25 | |
Infusion Set VL ON70 AirBlock | 2024/03/25 | |
Infusion Set VL ON72 AirBlock | 2024/03/25 | |
Infusion Set VL ON90 AirBlock | 2024/03/25 | |
Infusion Set VL PN95 | 2024/03/25 | |
Infusion Set VL PN96 | 2024/03/25 | |
GraviSet VarioLine with cover, ENFIT | 2024/03/27 | |
Freka® PEG Pro Set FR 12 | 2023/11/23 | |
Freka® PEG Pro Set FR 14 | 2023/11/23 | |
Freka® PEG Pro Set FR 20 | 2023/11/23 | |
Freka® PEG Pro Set FR 16 | 2023/11/23 | |
Repair Set for Freka® PEG Pro FR 12 | 2024/04/15 | |
Repair Set for Freka® PEG Pro FR 14 | 2024/04/15 | |
Repair Set for Freka® PEG Pro FR 16 | 2024/04/15 | |
Repair Set for Freka® PEG Pro FR 20 | 2024/04/15 | |
Connector for Freka® PEG Pro FR 12, ENFit | 2024/04/15 | |
Connector for Freka® PEG Pro FR 14, ENFit | 2024/04/15 | |
Connector for Freka® PEG Pro FR 16, ENFit | 2024/04/15 | |
Connector for Freka® PEG Pro FR 20, ENFit | 2024/04/15 | |
Freka® Tube Clamp for FR 12 – Freka® Tube Clamp for FR 14 | 2024/04/15 | |
Freka® Tube Clamp for FR 16 – Freka® Tube Clamp for FR 20 | 2024/04/15 | |
Fixation Plate for Freka® PEG Pro FR 12 | 2024/04/15 | |
Fixation Plate for Freka® PEG Pro FR 14 | 2024/04/15 | |
Fixation Plate for Freka® PEG Pro FR 16 | 2024/04/15 | |
Fixation Plate for Freka® PEG Pro FR 20 | 2024/04/15 | |
Ambix NONCORstick Safe 19G x 24 mm | 2024/03/22 | |
Ambix Intrastick Safe 19G x 24mm | 2024/03/22 | |
Freka PEG Pro Hybrid Set, FR 16 | 2023/12/04 | |
Ambix Intrastick® Safe 20G x 24mm | 2024/03/22 | |
Ambix Intrastick® Safe 22G x 24mm | 2024/03/22 | |
Ambix NONCORstick® Safe 20Gx24mm | 2024/03/22 | |
Ambix NONCORstick® Safe 22Gx24mm | 2024/03/22 | |
Lipifil Air 24h, 1.2 µm, 10 cm2 | 2024/04/30 | |
Infusion Set VL SP10-PE | 2024/03/25 | |
Infusion Set VL SP02-PE | 2024/03/25 | |
Infusion Set VL SP42-PE | 2024/03/25 | |
Infusion Set VL SP40-11-PE | 2024/03/25 | |
Freka® Intestinal Tube FR 12 for Freka PEG FR 20 | 2024/04/15 |
601_TF Enteral Feeding Tubes Percutaneous and Accessories_IIb_EU DoC_NEN60122b_15.04.2024
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Freka® Intestinal Tube FR 9 for Freka PEG FR 15 | 2024/04/15 |
601_TF Enteral Feeding Tubes Percutaneous and Accessories_IIb_EU DoC_NEN60122b_15.04.2024
|
Freka® Y Connector for PEG FR 15/9, 2xENFit | 2024/04/15 | |
Freka® Y Connector for PEG FR 20/9, 2xENFit | 2024/04/15 |
601_TF Enteral Feeding Tubes Percutaneous and Accessories_Is_EU DoC_NEN60131s_15.04.2024
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Freka® Y Connector for PEG FR 20/12, 2xENFit | 2024/04/15 | |
Freka® Intestinal Tube FR 9 for Freka PEG FR 16 | 2024/04/15 |
601_TF Enteral Feeding Tubes Percutaneous and Accessories_IIb_EU DoC_NEN60122b_15.04.2024
|
Freka® Y Connector Freka PEG FR 16/9, ENFit | 2024/04/15 | |
Freka® Y Connector for PEG FR 16/9, 2xENFit | 2024/04/15 | |
Infufil Air 120h, 0.2 µm, positive, 10 cm2 | 2024/04/30 | |
Injectomat® Syringe 50 ml, light protected | 2024/02/19 |