HEALTHIUM MEDTECH LIMITED

Certificate 2022-MDR/QS-005

Rev. 01Amended

Valid until: Aug 15, 2027

Certificate 2022-MDR/QS-005 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-005
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-00501

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-005Quality management systemIssuedAug 15, 2022 → Aug 15, 2027

Scope coverage

Class III17

17 scopes

BRAIDED AND COATED POLYGLYCOLIC ACID STERILE SYNTHETIC ABSORBABLE SURGICAL SUTURE
Class III
TRUGLYDE
Class III
ANNCRYL
Class III
I GLYDE
Class III
LINX PGA
Class III
POLYGLYCOLIC ACID
Class III
U-GLYDE
Class III
PGA RESORBA
Class III
SURGISUT TRUGLYDE
Class III
B-GLYDE
Class III
TRUVET POLYGLYCOLIC ACID
Class III
IM-GLYDE
Class III
ESORB
Class III
UNODENT PGA
Class III
POGAL
Class III
N-CARE PGA
Class III
ALAN GLYDE
Class III

Documents

LanguagesEN