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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

SWL-Origin — Class III MDD by SWL Medizin GmbH

MD Atlas
SWL Medizin GmbH

EUDAMED last updated this device on Sep 28, 2023

SWL-Origin

B-04251790266213

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SWL Medizin GmbH
UDI-DI code: 04251790266213
Reference / catalog number: PGW826621

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Manufacturer information

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

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

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Aug 14, 2020	May 26, 2024

Device identification

Trade name: SWL-Origin
UDI-DI code: 04251790266213
Basic UDI-DI: B-04251790266213
Reference / catalog number: PGW826621
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Guide Wire
Additional information URL: https://www.shunmed.com/
Clinical sizes: 0.014 MU28
300 MU10

EMDN nomenclature code(s)

C04010101CORONARY ARTERY DIAGNOSTIC GUIDEWIRES, HYDROPHILIC

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