BIOTRONIK SE & Co. KG

Certificate 20363GB448260407

Amended

Valid until: Sep 28, 2027

Certificate 20363GB448260407 is a valid Quality management system issued to BIOTRONIK SE & Co. KG and registered in EUDAMED. Valid until September 28, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 20363GB448260407
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 048220363GB448260407

Validity

Issued: Apr 7, 2026
Valid from: Apr 7, 2026
Valid until: Sep 28, 2027

Notified body

Notified body: DNV MEDCERT GmbH
Notified body SRN: 0482
Notified body country: Germany

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: Yes
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

Amended

Supersedes

20363GB448260114AmendedJan 13, 2026 → Sep 27, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2Class I1Class III1

4 scopes

MDN 1203
Class I
MDA 0305 EMDN Z120507
Class IIb
MDA 0305 EMDN Z120506
Class IIb
MDN 1203
Class III

Documents

LanguagesEN