BioCer Entwicklungs-GmbH

Certificate HZ 1450174-1

Rev. Rev. 1Supplemented

Valid until: Jul 25, 2029

Certificate HZ 1450174-1 is a valid Quality management system issued to BioCer Entwicklungs-GmbH and registered in EUDAMED. Valid until July 25, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 1450174-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 1450174-1Rev. 1

Validity

Issued: Jun 2, 2026
Valid from: Jun 2, 2026
Valid until: Jul 25, 2029

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: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HZ 1450174-1Quality management systemIssuedJul 26, 2024 → Jul 25, 2029

Scope coverage

Class III2Class I1

3 scopes

G020499 - Gastrointestinal Haemostasis Devices - Other
Class I
M040501 - Haemostatic Dressings Polysaccharide Haemostatic Dressings
Class III
P900204 - Surgical Meshes Surgical Meshes, more than one component
Class III

Documents

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