PulseLavage AB

Certificate M.2023.1014

Rev. 00Cancelled

Valid until: Apr 5, 2028

Certificate M.2023.1014, a Quality assurance issued to PulseLavage AB, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: M.2023.1014
Certificate type: Quality assurance
Certificate status: Cancelled
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 2696M.2023.101400

Validity

Issued: Apr 6, 2023
Valid from: Apr 6, 2023
Valid until: Apr 5, 2028

Manufacturer

Manufacturer: PulseLavage AB
Manufacturer SRN: SE-MF-000002363
Manufacturer country: Sweden

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: No
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

Cancelled

Supersedes

M.2023.1014Quality assuranceIssuedApr 6, 2023 → Apr 5, 2028

Scope coverage

Class I1

1 scope

Non-Sterile Reusable Channel Dissector
Class I

Documents

LanguagesEN