HEALTHIUM MEDTECH LIMITED

Certificate 2022-MDR/QS-007

Rev. 01Amended

Valid until: Aug 15, 2027

Certificate 2022-MDR/QS-007 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-007
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-00701

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-007Quality management systemIssuedAug 15, 2022 → Aug 15, 2027

Scope coverage

Class III18

18 scopes

TRUVET POLYDIOXANONE
Class III
IM- PDS
Class III
EXANONE
Class III
UNODENT PDO
Class III
N-CARE PD SYNTH
Class III
ALAN ANONE
Class III
PD SYNTH
Class III
VETSUTURE PDX
Class III
NOÉCARE PDX
Class III
NOÉDENTAL PDX
Class III
LINX PDO
Class III
PDX POLYDIOXONONE
Class III
Q-CLOSE PDSYNTH
Class III
PDO RESORBA
Class III
U- PD SYNTH
Class III
MONOFILAMENT POLYDIOXANONE STERILE SYNTHETIC ABSORBABLE SURGICAL SUTURE
Class III
SURGISUT PD SYNTH
Class III
B-PD SYNTH
Class III

Documents

LanguagesEN