B. Braun Melsungen AG

Certificate G10 012974 0611

Rev. Rev. 14Supplemented

Valid until: Mar 12, 2030

Certificate G10 012974 0611 is a valid Quality management system issued to B. Braun Melsungen AG and registered in EUDAMED. Valid until March 12, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 012974 0611
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 012974 0611Rev. 14

Validity

Issued: Feb 12, 2026
Valid from: Feb 12, 2026
Valid until: Mar 12, 2030

Notified body

Notified body: TÜV SÜD Product Service GmbH
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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

G10 012974 0611SupplementedJun 2, 2025 → Mar 11, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa24Class IIb5

29 scopes

A030101 - INFUSION CONTROLLERS
Class IIa
Z120303 - INFUSION INSTRUMENTS
Class IIb
A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Class IIa
Z12030382 - INFUSION INSTRUMENTS - SOFTWARE ACCESSORIES
Class IIb
A010101 - HYPODERMIC NEEDLES
Class IIa
C010101 - PERIPHERAL I.V. CATHETERS
Class IIa
A070199 - ADAPTERS AND CONNECTORS - OTHER
Class IIa
A040101 - ADMINISTRATION AND ASPIRATION FILTERS
Class IIa
A070501 - CAPS OR OBTURATORS, NON-PERFORABLE
Class IIa
A070502 - CAPS OR OBTURATORS, PERFORABLE
Class IIa
A060101 - VACUUM AND GRAVITY DRAINAGE SYSTEMS
Class IIa
A018003 - NEEDLE INTRODUCERS
Class IIa
A010302 - PLEXUS BLOCK NEEDLES AND KITS
Class IIa
A0703 - STOPCOCKS
Class IIa
A030103 - ENTERAL FEEDING CONTROLLERS
Class IIa
A030201 - EXTENSIONS
Class IIa
G020201 - NASOGASTRIC INTESTINAL TUBES
Class IIa
A070103 - INFUSION TUBING ADAPTERS AND CONNECTORS
Class IIa
A020106 - INSULIN SYRINGES, SINGLE-USE
Class IIa
A050101 - ELASTOMERIC SYSTEMS - FIXED FLOW
Class IIb

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Documents

LanguagesEN

Scope coverage

Class IIa24Class IIb5

29 scopes

A030101 - INFUSION CONTROLLERS
Class IIa
Z120303 - INFUSION INSTRUMENTS
Class IIb
A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Class IIa
Z12030382 - INFUSION INSTRUMENTS - SOFTWARE ACCESSORIES
Class IIb
A010101 - HYPODERMIC NEEDLES
Class IIa
C010101 - PERIPHERAL I.V. CATHETERS
Class IIa
A070199 - ADAPTERS AND CONNECTORS - OTHER
Class IIa
A040101 - ADMINISTRATION AND ASPIRATION FILTERS
Class IIa
A070501 - CAPS OR OBTURATORS, NON-PERFORABLE
Class IIa
A070502 - CAPS OR OBTURATORS, PERFORABLE
Class IIa
A060101 - VACUUM AND GRAVITY DRAINAGE SYSTEMS
Class IIa
A018003 - NEEDLE INTRODUCERS
Class IIa
A010302 - PLEXUS BLOCK NEEDLES AND KITS
Class IIa
A0703 - STOPCOCKS
Class IIa
A030103 - ENTERAL FEEDING CONTROLLERS
Class IIa
A030201 - EXTENSIONS
Class IIa
G020201 - NASOGASTRIC INTESTINAL TUBES
Class IIa
A070103 - INFUSION TUBING ADAPTERS AND CONNECTORS
Class IIa
A020106 - INSULIN SYRINGES, SINGLE-USE
Class IIa
A050101 - ELASTOMERIC SYSTEMS - FIXED FLOW
Class IIb

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Certificate G10 012974 0611

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate G10 012974 0611

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer