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

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SWL Medizin GmbH

Certificate MDR.2292-2026/0008

Rev. 0Issued
Valid until
Mar 11, 2031

Certificate MDR.2292-2026/0008 is a valid Technical documentation issued to SWL Medizin GmbH and registered in EUDAMED. Valid until March 11, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number
MDR.2292-2026/0008
Certificate type
Technical documentation
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
2292MDR.2292-2026/00080

Validity

Issued
Mar 12, 2026
Valid from
Mar 12, 2026
Valid until
Mar 11, 2031

Notified body

Notified body
UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
Notified body SRN
2292
Notified body country
Türkiye

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
—
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified1

1 scope

  • Coronary Cutting Balloon Dilatation Catheter
    42517902VBCVE

Documents

LanguagesEN

Manufacturer

Manufacturer
SWL Medizin GmbH
Manufacturer SRN
DE-MF-000008000
Manufacturer country
Germany

Covered devices

  • Coronary Cutting Balloon Dilatation CatheterClass III
    42517902VBCVE

Linked SSCPs

  • SSCP SWL-SSCP-VBC-001