MD Atlas
BlogPricingSign in
MD Atlas
Made In Tracker
Made In TrackerEasyUDI
Legal
Privacy PolicyLegal Notice
About
AboutFAQBlogPartnersContact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

  • MD Atlas
  • Documents

DK Medical Technology Co., Ltd.

Certificate M.2025.MDR.1062-1

Rev. 00Withdrawn
Valid until
Feb 17, 2028

Certificate M.2025.MDR.1062-1, a Technical documentation issued to DK Medical Technology Co., Ltd., has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number
M.2025.MDR.1062-1
Certificate type
Technical documentation
Certificate status
Withdrawn
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
2696M.2025.MDR.1062-100

Validity

Issued
Feb 18, 2025
Valid from
Feb 18, 2025
Valid until
Feb 17, 2028

Notified body

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

Characteristics

Sterile
—
Human tissues
—
Animal tissues
—
In vitro diagnostics
—
Initial registration
No
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
—
SPP applicable
—
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

Status changes

  • Withdrawn

Supersedes

  • M.2025.MDR.1062-1Technical documentationIssuedFeb 18, 2025 → Feb 17, 2028

Scope coverage

Unspecified1

1 scope

  • Coronary Scoring Balloon Dilatation Catheter
    69722536014CSL5K

Documents

LanguagesEN

Manufacturer

Manufacturer
DK Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000011218
Manufacturer country
China

Covered devices

  • Coronary Scoring Balloon Dilatation CatheterClass III
    69722536014CSL5K

Linked SSCPs

  • SSCP TD-09-6.2.6