B. Braun Medical AG

Certificate G15 061585 0043

Rev. Rev. 01Supplemented

Valid until: Mar 14, 2031

Certificate G15 061585 0043 is a valid Quality management system issued to B. Braun Medical AG and registered in EUDAMED. Valid until March 14, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: G15 061585 0043
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G15 061585 0043Rev. 01

Validity

Issued: Jun 25, 2026
Valid from: Jun 25, 2026
Valid until: Mar 14, 2031

Manufacturer

Manufacturer: B. Braun Medical AG
Manufacturer SRN: CH-MF-000017781
Manufacturer country: Switzerland

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

G15 061585 0043IssuedFeb 3, 2026 → Mar 14, 2031

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa6Class IIb3Class I2

11 scopes

M040499 - DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER
Class I
V9099 - VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER
Class I
MDN 1211 - Non-active non-implantable devices for disinfecting, cleaning and rinsing
Class IIa
MDN 1211 - Non-active non-implantable devices for disinfecting, cleaning and rinsing
Class IIa
MDN 1211 - Non-active non-implantable devices for disinfecting, cleaning and rinsing
Class IIa
MDN 1211 - Non-active non-implantable devices for disinfecting, cleaning and rinsing
Class IIa
MDN 1211 - Non-active non-implantable devices for disinfecting, cleaning and rinsing
Class IIa
MDN 1213 - Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
Class IIa
D01010102 - GLUTARALDEHYDE, ACIDIC SOLUTION FOR THE DISINFECTION OF MEDICAL DEVICES
Class IIb
D01010102 - GLUTARALDEHYDE, ACIDIC SOLUTION FOR THE DISINFECTION OF MEDICAL DEVICES
Class IIb
M040703 - WOUND DEBRIDEMENT PADS
Class IIb

Documents

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