BioRegen Biomedical (Changzhou) Co., Ltd.

Certificate G10 070340 0011

Rev. Rev. 00Issued

Valid until: Dec 2, 2029

Certificate G10 070340 0011 is a valid Quality management system issued to BioRegen Biomedical (Changzhou) Co., Ltd. and registered in EUDAMED. Valid until December 2, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 070340 0011
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 070340 0011Rev. 00

Validity

Issued: Jan 13, 2025
Valid from: Jan 13, 2025
Valid until: Dec 2, 2029

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: 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 IIa1

1 scope

M040405 - HYDROGEL DRESSINGS; /
Class IIa

Documents

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