Calbreak

by SWL Medizin GmbH 13 variants

Ref 835765

Active European Union

CE MDR

Valid until

11 Mar 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

Certifier UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number42517902VBCVE Basic UDI-DI 04251790257655UDI-DI	Date16 Mar 2026Registered	StatusActive
European Union	CE/MDR	NumberMDR.2292-2026/0008	Date12 Mar 2026Issued	StatusActive expires 11 Mar 2031

Certificates

1 certificate · EUDAMED

MDR.2292-2026/0008 Active

Technical documentation EU MDR

Certifier

UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292

Issued
12 Mar 2026

Expires
11 Mar 2031

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Coronary Cutting Balloon Dilatation Catheter
Model / Reference: 835765

Primary DI / UDI-DI: 04251790257655
Basic UDI-DI: 42517902VBCVE
EMDN Code: C010401020101 Ptca balloon dilation catheters

Device Class: Class III
EU market of registration: Türkiye

Manufacturer details

EUDAMED SRN: DE-MF-000008000

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Properties

Sterile

Other properties (12)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No