HEALTHIUM MEDTECH LIMITED

Certificate 2022-MDR/QS-008

Rev. 01Amended

Valid until: Aug 15, 2027

Certificate 2022-MDR/QS-008 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-008
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-00801

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-008Quality management systemIssuedAug 15, 2022 → Aug 15, 2027

Scope coverage

Class III19

19 scopes

MONOGLYDE
Class III
VETSUTURE PGC
Class III
NOÉCARE PGC
Class III
NOÉDENTAL PGC
Class III
PGC POLIGLECAPRONE 25
Class III
LINX MONO
Class III
Q-CLOSE MONO
Class III
FLYSORB MONO
Class III
U- MONOGLYDE
Class III
SURGISUT MONOGLYDE
Class III
B-ONOGLYDE
Class III
TRUVET POLIGLECAPRONE
Class III
IM –MONO
Class III
ECAPRONE
Class III
UNODENT PGCL
Class III
POGAL MONO
Class III
N-CARE MONOGLYDE
Class III
ALAN GLECA
Class III
MONOFILAMENT POLIGLECAPRONE 25 STERILE SYNTHETIC ABSORBABLE SURGICAL SUTURE
Class III

Documents

LanguagesEN