BEC GmbH

Certificate D1348500014

Supplemented

Valid until: Feb 17, 2027

Certificate D1348500014 is a valid Quality management system issued to BEC GmbH and registered in EUDAMED. Valid until February 17, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: D1348500014
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0483D1348500014

Validity

Issued: Jun 11, 2026
Valid from: Jun 11, 2026
Valid until: Feb 17, 2027

Manufacturer

Manufacturer: BEC GmbH
Manufacturer SRN: DE-MF-000006404
Manufacturer country: Germany

Notified body

Notified body
Notified body SRN: 0483
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

D1348500012SupplementedSep 8, 2025 → Feb 17, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2Class I1

3 scopes

exacure (Patientenpositionierungssystem für die Strahlentherapie)
Class IIb
guidoo roboticsystem
Class IIb
Sterile Nadelführungshülse für den Einmalgebrauch, erhältlich in verschiedenen Größen
Class I

Documents

LanguagesDE