Qubix Medicare Private Limited

Certificate 2025-MDR/QS-081/A

Rev. 01Amended

Valid until: Dec 2, 2030

Certificate 2025-MDR/QS-081/A is a valid Quality management system issued to Qubix Medicare Private Limited and registered in EUDAMED. Valid until December 2, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-081/A
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652025-MDR/QS-081/A01

Validity

Issued: Jun 3, 2026
Valid from: Jun 3, 2026
Valid until: Dec 2, 2030

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

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: Basic UDI-DI data only

History

Status changes

Amended

Supersedes

2025-MDR/TD-081IssuedDec 2, 2025 → Dec 2, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa2

2 scopes

SKIN STAPLERS, SINGLE-USE
Class IIa
DEVICE
Class IIa

Documents

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