Chetan Meditech Pvt. Ltd.

Certificate 2024-MDR/QS-040

Rev. 00Issued

Valid until: Jul 1, 2029

Certificate 2024-MDR/QS-040 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: 2024-MDR/QS-040
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652024-MDR/QS-04000

Validity

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

Manufacturer

Manufacturer: Chetan Meditech Pvt. Ltd.
Manufacturer SRN: IN-MF-000013541
Manufacturer country: India

Notified body

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

Covered devices

BIOTEK, Cannudrill, Flowertip, AI Reamer, Shuttleferry, Shuttleferry I, sHUTTLEFERRY II, Arthrovims OnLocClass I
89042103cmplins003YB

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I2

2 scopes

Orthopaedics surgical measurers, reusable
Class I
DEVICE
Class I

Documents

LanguagesEN