Protex Healthcare NV

Certificate M.2023.MDR.1031

Rev. 00Suspended

Valid until: Dec 14, 2027

Certificate M.2023.MDR.1031, a Quality management system issued to Protex Healthcare NV, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2023.MDR.1031
Certificate type: Quality management system
Certificate status: Suspended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2023.MDR.103100

Validity

Issued: Dec 15, 2023
Valid from: Dec 15, 2023
Valid until: Dec 14, 2027

Notified body

Notified body: UDEM Adriatic d.o.o.
Notified body SRN: 2696
Notified body country: Croatia

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: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Suspended
Suspended

Supersedes

M.2023.MDR.1031Quality management systemIssuedDec 15, 2023 → Dec 14, 2027

Scope coverage

Class IIb1

1 scope

VACUTEXTM Sterile Capillary wound dressing
Class IIb

Documents

LanguagesEN