Unknown / Not in EUDAMED

Snapshot 2026-10-12 · Link to EUDAMED

Single-Use Digital Flexible Ureteroscope

UDI-DI 06975202772915Basic UDI-DI 697520277023J9

Class IIa · MDR · Hunan Endoso Life Technology Co., Ltd

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Identification

Model: PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2
EMDN: Z12020705
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

6124105CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-04-20 · Expiry 2029-11-01

Scope not stated in certificate data.

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

Manufacturer

Hunan Endoso Life Technology Co., Ltd

SRN CN-MF-000021400

CN · Xiangtan City, Hunan Province

manufacturer

Authorised representative: Umedwings Netherlands B.V. (NL-AR-000000444)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/single-use-digital-flexible-ureteroscope-2915 · UDI page: /udi/06975202772915

All devices from Hunan Endoso Life Technology Co., Ltd

Scan an inventory CSV