Acandis GmbH

Certificate 1000308130

Rev. 14Supplemented

Valid until: Mar 22, 2028

Certificate 1000308130 is a valid Quality management system issued to Acandis GmbH and registered in EUDAMED. Valid until March 22, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000308130
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0297100030813014

Validity

Issued: May 29, 2026
Valid from: May 29, 2026
Valid until: Mar 22, 2028

Notified body

Notified body: DQS Medizinprodukte GmbH
Notified body SRN: 0297
Notified body country: Germany

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

Status changes

Supplemented

Supersedes

1000297995SupplementedMar 16, 2026 → Mar 22, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III19Class IIb2

20 scopes

MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
Class III
MDN 1101/B - Non-active neurovascular implants
Class IIbClass III
MDN 1202 - Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class IIb
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III

Documents

LanguagesEN