Unknown / Not in EUDAMED

Snapshot 2026-10-11 · Link to EUDAMED

Soni-Cerv LEEP

UDI-DI 00810026183690Basic UDI-DI 0081002618SFT-SKJ

Class IIb · MDR · Soniquence, LLC

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Identification

Model: SFT-S
EMDN: K0201010301
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

28620156587-01

EU quality management system · unknown

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2025-06-16 · Expiry 2028-02-12

Scope not stated in certificate data.

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

Manufacturer

Soniquence, LLC

SRN US-MF-000029810

US · Baldwin

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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Showing 12 of 92 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/soni-cerv-leep-3690 · UDI page: /udi/00810026183690

All devices from Soniquence, LLC

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