B. Braun Surgical, S.A.

Certificate G12 025701 0096

Rev. Rev. 07Supplemented

Valid until: Jul 18, 2027

Certificate G12 025701 0096 is a valid Quality management system issued to B. Braun Surgical, S.A. and registered in EUDAMED. Valid until July 18, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: G12 025701 0096
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G12 025701 0096Rev. 07

Validity

Issued: Feb 28, 2025
Valid from: Feb 28, 2025
Valid until: Jul 18, 2027

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: Yes
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

G12 025701 0096SupplementedSep 2, 2024 → Jul 17, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III7Class IIb1

8 scopes

H010101 - ABSORBABLE SYNTHETIC SUTURES
Class III
H900101 - GLUES
Class III
P900202 - POLYPROPYLENE SURGICAL MESHES
Class III
H010201 - NON-ABSORBABLE SYNTHETIC SUTURES
Class III
M040506 - HEMOSTATIC WAXES
Class IIb
H900303 - PLEDGETS
Class III
M040502 - ANIMAL COLLAGEN HAEMOSTATIC DRESSINGS
Class III
C020299 - CARDIAC TEMPORARY STIMULATION DEVICES (WITH OR WITHOUT ACTIVE SUBSTANCES) - OTHER
Class III

Documents

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