Chetan Meditech Pvt. Ltd.

Certificate 2024-MDR/TD-033

Rev. 0Issued

Valid until: Jan 7, 2029

Certificate 2024-MDR/TD-033 is a valid Technical documentation 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/TD-033
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652024-MDR/TD-0330

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, ONButton, ONButton-Ex, AK-FIX, WT-FIX, MR-FIX, PIVOT-FIX, AC-FIX, SMARTFIX, SUTUREFIX, BT-FIX, ONButton CL, BUTTONFIX, BUTTONFIX-F, BUTTONFIX-W, Class IIb
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Linked SSCPs

SSCP SSCP/03

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

BIOTEK, ONButton, ONButton-Ex, AK-FIX, WT-FIX, MR-FIX, PIVOT-FIX, AC-FIX, SMARTFIX, SUTUREFIX, BT-FIX, ONButton CL, BUTTONFIX, BUTTONFIX-F, BUTTONFIX-W,
89042103cmplimp004XD

Documents

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