medK GmbH

Certificate 20610GB450251015

Supplemented

Valid until: Oct 12, 2030

Certificate 20610GB450251015 is a valid Technical documentation issued to medK GmbH and registered in EUDAMED. Valid until October 12, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 20610GB450251015
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 048220610GB450251015

Validity

Issued: Oct 15, 2025
Valid from: Oct 15, 2025
Valid until: Oct 12, 2030

Manufacturer

Manufacturer: medK GmbH
Manufacturer SRN: DE-MF-000006273
Manufacturer country: Germany

Notified body

Notified body
Notified body SRN: 0482
Notified body country: Germany

Covered devices

Linked SSCPs

SSCP medK-GW-9826

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Supplemented

Supersedes

20610GB450251013IssuedOct 13, 2025 → Oct 12, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III5

5 scopes

MedK Diagnostic Guidewires
Class III
++B82798260LF
MedK Hydrophilic Guidewires
Class III
++B82798261LH
MedK Cardiovascular Guidewires
Class III
++B82798262LK
MedK Cardiovascular Guidewires
Class III
++B82798263LM
MedK Cardiovascular Guidewires
Class III
++B82798264LP

Documents

LanguagesEN