Chetan Meditech Pvt. Ltd.

Certificate 202-MDR/QS-034

Rev. 0Issued

Valid until: Jul 1, 2029

Certificate 202-MDR/QS-034 is a valid Quality management system issued to Chetan Meditech Pvt. Ltd. and registered in EUDAMED. Valid until July 1, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 202-MDR/QS-034
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2265202-MDR/QS-0340

Validity

Issued: Jul 1, 2024
Valid from: Jul 1, 2024
Valid until: Jul 1, 2029

Notified body

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

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Nonabsorbable Soft tissue and bone fixation devices - Meniscal repair devices
Class IIb
Meniscal Repair Devices
Class IIb

Documents

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