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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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Coronary Cutting Balloon Dilatation… — 36 UDI-DI variants, MDR

MD Atlas
SWL Medizin GmbH

Data from EUDAMED, last updated May 23, 2026

Coronary Cutting Balloon Dilatation Catheter

42517902VBCVE

36 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class III

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Manufacturer: SWL Medizin GmbH

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Device characteristics

No device characteristics flagged

Clinical investigations

Investigation number: ChiCTR2500102597
Registered: No

Legacy certificates

Certificate number: MDR.2292-2026/0008
Type: refdata.certificate-mdr-type.technical-documentation
Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. (2292)
Validity: Mar 12, 2026 → Mar 11, 2031

Identity & classification

Basic UDI-DI: 42517902VBCVE
Device name: Coronary Cutting Balloon Dilatation Catheter
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class III
Version date: Mar 16, 2026

Manufacturer & authorised representative

Manufacturer

Name: SWL Medizin GmbH
SRN: DE-MF-000008000
Country: Germany
Email: swl1@swlmed.de
Phone: +49(0)1748766188

Variants by status

UDI-DI variants

36 UDI-DI variants

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basicUdiUlid01KKT2JYFH0XJ15FZ9AYNFQHHR

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

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Calbreak04251790257693
Calbreak04251790255255

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