Name Category Publication date Reference File
EC Certificate Annex II excluding (4) No. G1 047402 0083 MDD 10 June 2024 EC_Certificate
(334.54Kb)
EC Certificate Annex V No. G2S 047402 0084 MDD 10 June 2024 EC_Certificate
(311.36Kb)
ISO 9001 Certificate ISO 12 May 2022 ISO9001_Certificate
(419.29Kb)
EC Certificate Annex II.4 No. G7 047402 0046 MDD 10 June 2024 EC_Certificate
(1.11Mb)
EU Certificate (Implantable Class IIb Devices and Class III Devices) G12 037258 0016 MDR 21 November 2023 EU_Certificate
(294.99Kb)
ISO 13485 MDSAP Certificate MDSAP 31 March 2023 ISO13485_Certificate
(440.58Kb)
EU Certificate (Implantable Class IIb Devices and Class III Devices) G70 037258 0025 MDR 21 November 2023 EU_Certificate
(300.03Kb)
ISO 13485 Certificate ISO 11 March 2024 ISO13485_Certificate
(357.6Kb)
EU Certificate (Class IIa and Class IIb Devices) G10 037258 0012 MDR 11 March 2024 EU_Certificate
(300.39Kb)
EU Certificate (Class I Devices in sterile condition, with measuring function or reusable surgical instruments) G11 037258 0015 MDR 11 March 2024 EU_Certificate
(298.69Kb)
Confirmation Letter_Fresenius Kabi AG_Is_IIa_IIb_037258 0044 Rev. 00 MDD 17 April 2024 EC_Certificate
(538.13Kb)
Confirmation Letter_Fresenius Kabi AG_Conox_037258 0043 Rev. 00 MDD 17 April 2024 EC_Certificate
(361.83Kb)
Confirmation Letter_Fresenius Kabi AG_IIb implantable_III_037258 0045 Rev. 00 MDD 13 May 2024 EC_Certificate
(306.21Kb)
EC Certificate Annex II.4 No. G7 047402 0087 MDD 10 June 2024 EC_Certificate
(306.08Kb)
Confirmation Letter EU2023-607/727167 MDD 10 June 2024 EC_Certificate
(242.48Kb)