BMV Bender Medical Vertrieb GmbH

Certificate HZ 1202944-1

Rev. Rev. 2Issued

Valid until: Dec 20, 2030

Certificate HZ 1202944-1 is a valid Quality management system issued to BMV Bender Medical Vertrieb GmbH and registered in EUDAMED. Valid until December 20, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1202944-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1202944-1Rev. 2

Validity

Issued: Dec 16, 2025
Valid from: Dec 21, 2025
Valid until: Dec 20, 2030

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
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

No status changes or preceding certificates are recorded.

Scope coverage

Class I1Class IIa1Class IIb1

3 scopes

Products of class I, sterile: R010580 - Tracheostomy and Laringectomy Cannulas - Accessories The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Class I
Products of class IIa: R010580 - Tracheostomy and Laringectomy Cannulas - Accessories V030299 - Dimensional Clinical Parameters Measuring Devices – Other
Class IIa
Products of class IIb: Tracheostomy and Laringectomy Cannulas R010501 - Tracheostomy and Laringectomy Cannulas and Kits, Uncuffed R010502 - Tracheostomy and Laringectomy Cannulas and Kits, Cuffed R010503 - Tracheostomy Inner Cannulas
Class IIb

Documents

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