HEALTHIUM MEDTECH LIMITED

Certificate 2022-MDR/QS-009

Rev. 01Amended

Valid until: Aug 15, 2027

Certificate 2022-MDR/QS-009 is a valid Quality management system issued to HEALTHIUM MEDTECH LIMITED and registered in EUDAMED. Valid until August 15, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 2022-MDR/QS-009
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652022-MDR/QS-00901

Validity

Issued: Oct 18, 2022
Valid from: Oct 18, 2022
Valid until: Aug 15, 2027

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: No
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Amended

Supersedes

2022-MDR/QS-009Quality management systemIssuedAug 15, 2022 → Aug 15, 2027

Scope coverage

Class III21

21 scopes

BLACK BRAIDED SILK STERILE NON-ABSORBABLE SURGICAL SUTURE
Class III
TRUSILK
Class III
VETSUTURE SILK
Class III
NOÉCARE SILK
Class III
NOÉDENTAL SILK
Class III
ALPHA-SILK
Class III
ISILK
Class III
LINX SILK
Class III
Q-CLOSE SILK
Class III
U-SILK
Class III
SETA
Class III
SEIDE
Class III
SURGISUT TRUSILK
Class III
TRUVET SILK
Class III
IM- SILK
Class III
ESILK
Class III
UNODENT SILK
Class III
ALAN SILK
Class III
SILK
Class III
SILK CUT
Class III

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