Resource Center

Certificates

Quality Management

ISO 9001

文件名
ISO_9001_2015_en.pdf
大小
328 KB
格式
pdf
ISO 9001

ISO 13485

文件名
ISO_13485_2016_Fresenius_Kabi_AG_Q5_037258_0026_Rev03_31Mar2025.pdf
大小
357 KB
格式
pdf
ISO 13485

ISO 13485 MDSAP Certificate

文件名
ISO-13485-MDSAP-Certificate_QS6-037258-0030-Rev.-00_02.pdf
大小
440 KB
格式
pdf
ISO 13485 MDSAP Certificate

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

文件名
Certificate_G10_037258_0012_Rev02_09Mar2026.pdf
大小
300 KB
格式
pdf
MDR EU certificate G10 (Class IIa and Class IIb Devices)

MDR EU Certificate G11 (Class Is Devices)

文件名
Certificate_G11_037258_0015_Rev01_31Jul2027.pdf
大小
298 KB
格式
pdf
MDR EU certificate G11 (Class Is Devices)

MDR EU certificate G12 (Implantable Class IIb Devices)

文件名
Certificate G12 037258 0016 Rev 01_08Aug2027.pdf
大小
298 KB
格式
pdf
MDR EU certificate G12 (Implantable Class IIb Devices)

MDD Annex II excluding (4)

文件名
EC-Certificate-Annex-II-excluding-4-_G1-047402-0083-Rev.-00-.pdf
大小
334 KB
格式
pdf
MDD Annex II excluding (4)

MDD Annex II.4

文件名
EC-Certificate-Annex-II.4-Fresenius-Kabi-AG-G7-047402-0046-R.pdf
大小
1 MB
格式
pdf
MDD Annex II.4

MDD Annex V

文件名
EC-Certificate-Annex-V-Fresenius-Kabi-AG_G2S-47402-0084-Rev..pdf
大小
311 KB
格式
pdf
MDD Annex V

Environmental Management

Environmental Policy

文件名
EnvironmentalPolicy_August2023.pdf
大小
118 KB
格式
pdf
Environmental Policy

ISO 14001 Certificate

文件名
iso-14001-certificate-fresenius-kabi.pdf
大小
271 KB
格式
pdf
ISO 14001

Energy Management

DIN EN ISO 50001:2018 Fresenius Kabi

文件名
iso-50001-certificate-fresenius-kabi.pdf
大小
250 KB
格式
pdf
ISO 50001

Occupational Health and Safety Management

ISO 45001 Certificate

文件名
iso-45001-certificate-fresenius-kabi.pdf
大小
269 KB
格式
pdf
ISO 45001

Code of Conduct

Fresenius Kabi Code of Conduct

文件名
Fresenius-Kabi-Code-of-Conduct-2022.pdf
大小
7 MB
格式
pdf
Fresenius Kabi Code of Conduct

Fresenius Kabi Third Party Code of Conduct

文件名
Fresenius-Kabi-Third-Party-Code-of-Conduct.pdf
大小
2 MB
格式
pdf
Third Party Code of Conduct

Global Speak Up Policy

Global Speak Up Policy

文件名
Global-Speak-Up-Policy.pdf
大小
440 KB
格式
pdf
Global Speak Up Policy

Global Speak Up Policy - Annex

文件名
Annex-Global-Speak-Up-Policy.pdf
大小
81 KB
格式
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

文件名
Information_according_to_Article_33_-_Medical_Devi.pdf
大小
73 KB
格式
pdf
Information according to Article 33 - Medical Devices

Information according to Article 33 - Medicinal Products

文件名
Information_according_to_Article_33_-_Medicinal_Pr.pdf
大小
76 KB
格式
pdf
Information according to Article 33 - Medicinal Products