KULZER GmbH

Certificate HZ 1198082-1

Issued

Valid until: Nov 14, 2026

Certificate HZ 1198082-1 — a Quality management system issued to KULZER GmbH — is approaching its expiry. Valid until November 14, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1198082-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 1198082-1

Validity

Issued: Nov 14, 2022
Valid from: Nov 14, 2022
Valid until: Nov 14, 2026

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: No
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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa6

6 scopes

Q010101
Class IIa
Q010699
Class IIa
Q010201
Class IIa
Q0101601
Class IIa
Q010104
Class IIa
Q019008
Class IIa

Documents

LanguagesEN