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Certificates

Quality Management

ISO 9001

Filename
ISO_9001_2015_en.pdf
Size
328 KB
Format
pdf
ISO 9001

ISO 13485

Filename
ISO_13485_2016_Fresenius_Kabi_AG_Q5_037258_0026_Rev03_31Mar2025.pdf
Size
357 KB
Format
pdf
ISO 13485

ISO 13485 MDSAP Certificate

Filename
ISO-13485-MDSAP-Certificate_QS6-037258-0030-Rev.-00_02.pdf
Size
440 KB
Format
pdf
ISO 13485 MDSAP Certificate

MDR EU certificate G10 (Class IIa and Class IIb Devices)

Filename
Certificate_G10_037258_0012_Rev02_09Mar2026.pdf
Size
300 KB
Format
pdf
MDR EU certificate G10 (Class IIa and Class IIb Devices)

MDR EU Certificate G11 (Class Is Devices)

Filename
Certificate_G11_037258_0015_Rev01_31Jul2027.pdf
Size
298 KB
Format
pdf
MDR EU certificate G11 (Class Is Devices)

MDD Annex II excluding (4)

Filename
EC-Certificate-Annex-II-excluding-4-_G1-047402-0083-Rev.-00-.pdf
Size
334 KB
Format
pdf
MDD Annex II excluding (4)

MDD Annex II.4

Filename
EC-Certificate-Annex-II.4-Fresenius-Kabi-AG-G7-047402-0046-R.pdf
Size
1 MB
Format
pdf
MDD Annex II.4

MDD Annex V

Filename
EC-Certificate-Annex-V-Fresenius-Kabi-AG_G2S-47402-0084-Rev..pdf
Size
311 KB
Format
pdf
MDD Annex V

Environmental Management

Environmental Policy

Filename
EnvironmentalPolicy_August2023.pdf
Size
118 KB
Format
pdf
Environmental Policy

ISO 14001

Filename
ISO-14001-Certificate.pdf
Size
266 KB
Format
pdf
ISO 14001
Filename
ISO-14001-Certificate-Annex.pdf
Size
226 KB
Format
pdf
ISO 14001 - Annex I - Certified Sites

Energy Management

Microsoft Word - 1600177-407-EN-HZ-Änderung Standorterweiterung.DOCX

Filename
ISO-50001-Certificate.pdf
Size
266 KB
Format
pdf
ISO 50001
Filename
ISO-50001-Certificate-Annex.pdf
Size
279 KB
Format
pdf
ISO 50001 - Annex I - Certified Sites

Occupational Health and Safety Management

ISO 45001

Filename
ISO-45001-Certificate.pdf
Size
266 KB
Format
pdf
ISO 45001

ISO 45001 - Annex

Filename
ISO-45001-Certificate-Annex.pdf
Size
243 KB
Format
pdf
ISO 45001 - Annex

Code of Conduct

Fresenius Kabi Code of Conduct

Filename
Fresenius-Kabi-Code-of-Conduct-2022.pdf
Size
7 MB
Format
pdf
Fresenius Kabi Code of Conduct

Fresenius Kabi Third Party Code of Conduct

Filename
Fresenius-Kabi-Third-Party-Code-of-Conduct.pdf
Size
2 MB
Format
pdf
Third Party Code of Conduct

Global Speak Up Policy

Global Speak Up Policy

Filename
Global-Speak-Up-Policy.pdf
Size
440 KB
Format
pdf
Global Speak Up Policy

Global Speak Up Policy - Annex

Filename
Annex-Global-Speak-Up-Policy.pdf
Size
81 KB
Format
pdf
Global Speak Up Policy - Annex

Other documents

On June 1, 2007 the new European Chemicals Regulation REACH (Registration, Evaluation and Authorization of CHemicals) came into force.

The aim of REACH is to improve the protect​ion of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. REACH applies to manufacturers, importers and downstream user of chemicals within the EU.

Fresenius Kabi complies with the REACH regulation for all relevant substances.

In the REACH process Fresenius Kabi is mainly concerned as downstream user of chemical substances. As a downstream user of substances and preparations we are fulfilling our legal obligations under REACH.

In the rare cases were Fresenius Kabi is producer or importer from non-EU countries all relevant substances are pre-registered to comply with REACH.

If you have any questio​ns on our REACH policy, please do not hesitate to contact us.

Contact: reach@fresenius-kabi.com

Information according to Article 33 - Medical Devices

Filename
Information_according_to_Article_33_-_Medical_Devi.pdf
Size
73 KB
Format
pdf
Information according to Article 33 - Medical Devices

Information according to Article 33 - Medicinal Products

Filename
Information_according_to_Article_33_-_Medicinal_Pr.pdf
Size
76 KB
Format
pdf
Information according to Article 33 - Medicinal Products