HEALTHIUM MEDTECH LIMITED

Certificate 2022-MDR/QS-002

Rev. 00Issued

Valid until: Jun 2, 2027

Certificate 2022-MDR/QS-002 is a valid Quality management system issued to HEALTHIUM MEDTECH LIMITED and registered in EUDAMED. Valid until June 2, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2022-MDR/QS-002
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652022-MDR/QS-00200

Validity

Issued: Jun 2, 2022
Valid from: Jun 2, 2022
Valid until: Jun 2, 2027

Manufacturer

Manufacturer: HEALTHIUM MEDTECH LIMITED
Manufacturer SRN: IN-MF-000008421
Manufacturer country: India

Notified body

Notified body
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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa3

3 scopes

Sterile Latex Surgical Gloves - Pre Powdered Sterile Latex Surgical Gloves - Powder Free
Class IIa
Sterile Latex Surgical Gloves - Pre Powdered
Class IIa
Sterile Latex Surgical Gloves - Powder Free
Class IIa

Documents

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