HEALTHIUM MEDTECH LIMITED

Certificate 2022-MDR/QS-010

Rev. 01Amended

Valid until: Aug 15, 2027

Certificate 2022-MDR/QS-010 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-010
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-01001

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-010Quality management systemIssuedAug 15, 2022 → Aug 15, 2027

Scope coverage

Class III21

21 scopes

MONOFILAMENT POLYAMIDE (NYLON) STERILE NON-ABSORBABLE SURGICAL SUTURE
Class III
TRULON
Class III
VETSUTURE NYLON
Class III
NOÉCARE NYLON
Class III
NOÉDENTAL NYLON
Class III
ALPHA-LON
Class III
LINX NYLON
Class III
NYLON POLYAMIDE
Class III
Q-CLOSE NYLON
Class III
U-LON
Class III
MONOMYD
Class III
SURGISUT TRULON
Class III
B-LON
Class III
TRUVET NYLON
Class III
IM-LON
Class III
ELYAMIDE
Class III
UNODENT NYLON
Class III
ALAN LON
Class III
NYLAMID
Class III
N-CARE NYLON
Class III

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