Certificate valid

Snapshot 2026-10-28 · Link to EUDAMED

Locaste

UDI-DI 06941903006635Basic UDI-DI 69419030PICA8FM5

Class III · MDR · Hangzhou LEEKAI Technology Co., Ltd

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Identification

Model: PICA8F80S PICA8FG80S PICA8F80MPS PICA8FG80MPS PICA8F90S PICA8FG90S PICA8F90MPS PICA8FG90MPS PICA8F100S PICA8FG100S PICA8F100MPS PICA8FG100MPS
EMDN: C0104010202
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

MDR 804468

EU technical documentation assessment · valid

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

Valid from 2025-12-17 · Expiry 2030-12-16

Scope not stated in certificate data.

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

Manufacturer

Hangzhou LEEKAI Technology Co., Ltd

SRN CN-MF-000039215

CN · Hangzhou, Zhejiang

manufacturer

Authorised representative: MedNet EC-REP C III GmbH (DE-AR-000011196)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/locaste-6635 · UDI page: /udi/06941903006635

All devices from Hangzhou LEEKAI Technology Co., Ltd

Scan an inventory CSV