HEALTHIUM MEDTECH LIMITED

Certificate 2022-MDR/QS-006

Rev. 01Amended

Valid until: Aug 15, 2027

Certificate 2022-MDR/QS-006 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-006
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-00601

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-006Quality management systemIssuedAug 15, 2022 → Aug 15, 2027

Scope coverage

Class III19

19 scopes

BRAIDED AND COATED POLYGLACTIN 910 STERILE SYNTHETIC ABSORBABLE SURGICAL SUTURE
Class III
TRUSYNTH
Class III
VETSUTURE PGLA
Class III
NOÉCARE PGLA
Class III
NOÉDENTAL PGLA
Class III
ALPHA-CRYIL
Class III
ISYNTH
Class III
POLYGLACTIN
Class III
Q-CLOSE SYNTH
Class III
U-SYNTH
Class III
SURGISUT TRUSYNTH
Class III
B-SYNTH
Class III
TRUVET POLYGLACTIN
Class III
FLYSORB
Class III
IM– SYNTH
Class III
ECRYL
Class III
UNODENT PGLA
Class III
POGAL 910
Class III
N- CARE POLYGLACTIN 910
Class III

Documents

LanguagesEN