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UDI Compass
Certificate valid

Snapshot 2026-10-19 · Link to EUDAMED

UNISYNTH PDS

UDI-DI 08904300127837Basic UDI-DI 890430012015ULSSS0094Z

Class III · MDR · Unisur Lifecare Private Limited

Identification
Model
9E70DZ25
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

2025-MDR/TD-007/A

EU technical documentation assessment · 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.

2025-MDR/QS-007/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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Canonical device page: /device/unisynth-pds-7837 · UDI page: /udi/08904300127837

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