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BODE Chemie GmbH

Germany DE-MF-000005851 Last updated 21 Oct 2026

Devices
80
Registries
EUDAMED
FDA recalls
0

Catalogue80

Page 1 of 2

Showing 1-50 of 80

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 0482 1 certificate

  • 0523GB448251013 Issued

    Quality management system EU MDR

    Issued
    13 Oct 2025
    Expires
    12 Nov 2030
    Valid from
    13 Nov 2025

Notified bodies

  • Notified body 0482

About

One of the leading manufacturers of disinfection and hygiene products (e.g. sterillium) and for skin protection – for clinic, practice, industry and household.

Translated from the manufacturer's own website. Source

What BODE Chemie GmbH makes

BODE Chemie GmbH manufactures single-use disinfectant tissues, including variants such as Bacillol Tissues, Bacillol 30 Sensitive Tissues, and Bacillol Zero Tissues, as well as foam-based disinfectant products like Bacillol 30 Sensitive Foam. The company also produces Mikrobac Tissues and Korsolex extra, a disinfectant solution, alongside single-use pump dispensers and safety wipes packaged in the BODE X-Wipes Safety Pack.

The company’s products are classified under EU Medical Device Regulations as Class I, Class IIa, and Class IIb devices and are registered in the EU’s eudamed database. BODE Chemie GmbH is based in Germany.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does BODE Chemie GmbH manufacture?

BODE Chemie GmbH specializes in single-use disinfection and hygiene products. These include disinfectant tissues like Bacillol Tissues, Bacillol 30 Sensitive Tissues, and Bacillol Zero Tissues, as well as foam-based disinfectant products such as Bacillol 30 Sensitive Foam. The company also produces Mikrobac Tissues, Korsolex extra (a disinfectant solution), single-use pump dispensers, and safety wipes packaged in the BODE X-Wipes Safety Pack. These products are designed for use in clinical, industrial, and household settings.

Where is BODE Chemie GmbH based?

BODE Chemie GmbH is headquartered in Germany. The company’s location in Germany aligns with its focus on manufacturing and distributing medical devices within the European market, particularly under EU Medical Device Regulations.

Which regulatory registries list BODE Chemie GmbH’s medical devices?

BODE Chemie GmbH’s medical devices are registered in the eudamed database, which is the official EU database for medical devices. This registry ensures transparency and compliance with EU Medical Device Regulations, allowing stakeholders to verify the company’s listed devices.

How are BODE Chemie GmbH’s medical devices classified under EU regulations?

BODE Chemie GmbH’s devices are classified under the EU Medical Device Regulations as Class I, Class IIa, and Class IIb products. Classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, single-use disinfectant tissues like Bacillol Zero Tissues are typically lower-risk (Class I or IIa), while more complex products like Korsolex extra (a disinfectant solution) may fall into higher-risk categories like Class IIb due to their active ingredients and potential for direct patient contact.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Germany
Address
27, Melanchthonstr. , Hamburg, Germany
PRRC contact
Thekla Bredthauer
EUDAMED SRN
DE-MF-000005851