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UDI Compass
Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

iSmart

UDI-DI 08908003989204Basic UDI-DI 8908003989nice8050M4

Class IIa · MDR · nice Neotech Medical Systems Pvt. Ltd.,

Identification
Model
nice 8050, nice 8010
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

1000170230

EU quality management system · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2024-08-15 · Expiry 2028-10-01

Scope not stated in certificate data.

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

Manufacturer

nice Neotech Medical Systems Pvt. Ltd.,

SRN IN-MF-000010243

IN · Chennai

manufacturer

Authorised representative: Amstermed B.V. (NL-AR-000001971)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ismart-9204 · UDI page: /udi/08908003989204

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