Certificate valid

Snapshot 2026-10-13 · Link to EUDAMED

Helix

UDI-DI 04251790218588Basic UDI-DI 42517902MDS10EN

Class III · MDR · SWL Medizin GmbH

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Identification

Model: MDS 10
EMDN: Z12109001
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

1TD-MDR-0065/06/2026/02

EU technical documentation assessment · valid

Notified body: Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi (2764)

Valid from 2026-06-05 · Expiry 2029-06-04

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

SWL Medizin GmbH

SRN DE-MF-000008000

DE · Darmstadt

manufacturer

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/helix-8588 · UDI page: /udi/04251790218588

All devices from SWL Medizin GmbH

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