Qubix Medicare Private Limited

Certificate 2025-MDR/QS-040/B

Rev. 02Amended

Valid until: Aug 7, 2030

Certificate 2025-MDR/QS-040/B is a valid Quality management system issued to Qubix Medicare Private Limited and registered in EUDAMED. Valid until August 7, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-040/B
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 22652025-MDR/QS-040/B02

Validity

Issued: Jun 8, 2026
Valid from: Jun 8, 2026
Valid until: Aug 7, 2030

Manufacturer

Manufacturer: Qubix Medicare Private Limited
Manufacturer SRN: IN-MF-000042759
Manufacturer country: India

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

Braided and Coated Polyglactin 910 SutureClass III
890612217ABSK7

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

History

Status changes

Amended

Supersedes

2025-MDR/QS-040/AQuality management systemSupplementedMar 6, 2026 → Aug 7, 2030

Scope coverage

Class III2

2 scopes

Braided and Coated Polyglactin 910 Suture
Class III
DEVICE
Class III

Documents

LanguagesEN