= Confidential - th gsm ration of Conformity with article list ha £U DECLARATION OF CONFORMITY. ‘Annex IX, chapter I and II of Regulation 217/748 according to EC-certifiate ‘No, G10 037258 0012 and Expiration Date March 03th, 2026 ‘sued by Notified Body TUV SUd Product Service GmbH, Aidlerstrasse 65, 80339 Munich, Germany, Identfeation Number 0123 Product Family Description Volumetric Infusion Pump Product name Refer to attachment Article number Refer to attachment From serial number / Batch number Refer to attachment [AGILIA VP range: Rule 12, Class Ib we Fresenius Kabi AG, Else-Kroner-Str. 1, 61352 Bad Homburg, Germany ‘Single Registration Number (SRN): DE-MF-00009273, manufacturer of the above procucts, hereby daclare under our sole responsibilty for this Declaration of Conformity thatthe referenced products comply with all relevant provisions of the Medical Device Regulation 2017/745 and any other relevant Union legislation that provides for the Issulng of this EU Declaration of Conformity. The products comply with the general safety and performance requirements of Annex I, further applicable standards ancfor other ormative documents as listed In the appleable technical documentaton. All supprting documentation Is kept under the premises of the manufacturer a fring om rd i, 2622 aarneKELER i Regn Are anager {| ‘Source of for Gb Fox 00003205, Vversons 4.0 ge dota Doce: OTO131_DEC-MOR-¢= Confidential - th aes EU Declars n of Conformity wi ith article list N KABI FRESENIUS Attachment to EU DECLARATION OF CONFORMITY ouumernic x4ruston PUP AGrLIA ve ‘ide Product name | Seal number 7 [Bas UDTDI ruber Batch number 7019510 [AGLA Ve RR | 25189362 zoissi2 fate oruavenca | NEY 7ni8520 [AGIA VDE | 282P0H06 7019551 AGILIA VP MEA | 25058786 2019595 Tver ncniavers [EYE 2019537 Not yet Livenvveladanl manufactured 2019543 AGILIA VP PT Lee sass —[auineree [Sen -4052682811020120CFD00RDF 018557 | AGILA VP DK | 25144362 zoisse0__|Astuaverr | 25144362 018570 | AGILAVP NC | #5144362 zoisse0 | AGIA PES | 987953 018569 | AGILAVPISE | 25144351 zoisss2[actuaveny [MEY z019597 hers cia vein [NEY ag Doere: OTO121_OEC NOR-¢= Confidential - Sh ase EU Declaration of Confort ity with article list AGILIA VP Mc ‘Artie | Product name | Serial number 7] Basie UDI-DT umber Bateh number 72019610 | AGILIA VP MC FR | 25144362 "2019612 | AGILIA VP MC NOA | AGILIA vp MC TH "2019620 | AGILIA VPMC DE _| 24999406 "2019631 | AGILIA VP MC MEA | 25059746 Nt yet zoi963s—[actiaveme ta [NEVE Nat yet 2019637 [aciuavemcmy [NOVEL 72019641 | AGILIA VP MC CO_| AGILIA v mc TH 72019643 | AGILIA VP Mc PT _| AGILIA VP MC TH 72019650 | AGILIA VPC SE_| 25144362 72019651 | AGILIA VP MC FI | 24967953 14052682A1V020126CFOOOADF 72019657 | AGILIA VP MC DK | 25144362 7019660 | AGILIA VP MC IT | 25144362 72019670 | AGILIA VP MC NL_| 25144362 zois681 | AGILIA VP Mc cL_| 25144452 7019689 [ AGILIA VP MC Ise | 25144351 7019691 [ AGILIA PMC Za _| 25144452 Not yet zoises2[aciuiavenc au [Move ag ot yet zo1s6s7_[aciuavemcin [Note ‘Doce DTOISt_DEC NOR-4= Confidential - th eee EU Declaration of Conformity with article list AGILIA VP Mc wiFE ‘cle Product name Serie! narsber 7] Base UDIDI amber Batch number 2019710 | AiLIA Mewar | 2514962 AGILIA VP WF RO et ete NOA manufactured zoisza0 | ASTI VP EW | BPO Fon S5057 Actua ve we wart | 2be3036 zoisro | AG 2 - from 2458576 Toasra [SRR VP Rw BOHN CILIA VP-WC-WIF | Wot jeuiee| TH manufactured TUR VFM WF Na et. 2019737 My manufactured -oxs7ae [ASR VP WE Wa tat 7019741 a Ea 4052682AIV02012bCFOOOADF 2019750 | AGRIAVEMC WIFTSE| sste4362 | zoxs7st [Astin ve mc wit | 2967952 zossrsy | ASA VP We WF | asi962 Z015760 | AGLI VP MC WITT | BSTHASEE Z019770 | AGIUAVPNC WIFT nL | 25164362 2015700 | AGLIAVoMe WLS | 24067953 oxs7en [UA VP we WiFi zoisran [AGUA VP RE WI sia2 TACTUR VP WO WORT Natya ena) AU manufactured 2019797 [actin vemcwirtin | RYE ag