Certificate valid

Snapshot 2026-10-19 · Link to EUDAMED

UNILENE

UDI-DI 08904300105347Basic UDI-DI 890430012015ULSSS0084X

Class IIb · MDR · Unisur Lifecare Private Limited

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Identification

Model: 8C70DZ36H
EMDN: H010201010401
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

2025-MDR/QS-008/A

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2026-01-08 · Expiry 2030-01-31

Scope not stated in certificate data.

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

Manufacturer

Unisur Lifecare Private Limited

SRN IN-MF-000008184

IN · Bangalore, Karnataka

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/unilene-5347 · UDI page: /udi/08904300105347

All devices from Unisur Lifecare Private Limited

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