Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

LeSifter Left Atrial Appendage Closure Device

UDI-DI 06935484703007Basic UDI-DI 69354847MDP10TX

Class III · MDR · Nanjing YDB Medical Technology Co., Ltd.

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Identification

Model: YFDQ-20-1 YFDQ-20-2 YFDQ-24-1 YFDQ-24-2 YFDQ-27-1 YFDQ-27-2 YFDQ-31-1 YFDQ-31-2 YFDQ-35-1 YFDQ-35-2
EMDN: P070404
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

MDR 812566

EU technical documentation assessment · valid

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-04-20 · Expiry 2031-04-19

Scope not stated in certificate data.

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

Manufacturer

Nanjing YDB Medical Technology Co., Ltd.

SRN CN-MF-000045826

CN · Nanjing City, Jiangsu

manufacturer

Authorised representative: SUNGO Europe B.V. (NL-AR-000000247)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/lesifter-left-atrial-appendage-closure-device-3007 · UDI page: /udi/06935484703007

All devices from Nanjing YDB Medical Technology Co., Ltd.

Scan an inventory CSV