Chetan Meditech Pvt. Ltd.

Certificate 2024-MDR/QS-037

Rev. 0Issued

Valid until: Jan 7, 2029

Certificate 2024-MDR/QS-037 is a valid Quality management system issued to Chetan Meditech Pvt. Ltd. and registered in EUDAMED. Valid until January 7, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/QS-037
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-0370

Validity

Issued: Jan 7, 2024
Valid from: Jan 7, 2024
Valid until: Jan 7, 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, BioFix-NP, BioFix-DF, BioFixClass IIb
89042103cmplimp003XB

Linked SSCPs

SSCP SSCP/07

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Osteosynthesis compression plates
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN