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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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Organization name
UDI-DI code
Reference / catalog number

Calbreak — Class III MDR by SWL Medizin GmbH

MD Atlas
SWL Medizin GmbH

EUDAMED last updated this device on Mar 16, 2026

Calbreak

42517902VBCVE

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SWL Medizin GmbH
UDI-DI code: 04251790255231
Reference / catalog number: 835523

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Manufacturer information

Organization name: SWL Medizin GmbH
SRN: DE-MF-000008000
Manufacturer status: Active

Related devices

MigressB-04251790276106On the market MigressB-04251790276021On the market MigressB-04251790276069On the market NavigatorB-04251790276342On the market MigressB-04251790276052On the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Türkiye; available across 1 country total.

Country	On market since	Until
TürkiyePrimary placement	Mar 13, 2026	Mar 13, 2036

Device identification

Trade name: Calbreak
UDI-DI code: 04251790255231
Basic UDI-DI: 42517902VBCVE
Reference / catalog number: 835523
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

C010401020101PTCA BALLOON DILATION CATHETERS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Certificates

Certificate health across this manufacturer's portfolio.

MDR.2292-2026/0007Issued
Quality management systemNotified body: 2292Expiry: Mar 11, 2031
MDR.2292-2026/0008Issued
Technical documentationNotified body: 2292Expiry: Mar 11, 2031