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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Rooti Rx

UDI-DI 04719873370092Basic UDI-DI 471987337RootiRxDJ

Class IIa · MDR · Rooti Labs Limited.

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

TW24/00000573

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2024-11-07 · Expiry 2029-07-12

Scope not stated in certificate data.

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

Manufacturer

Rooti Labs Limited.

SRN TW-MF-000004839

TW · Taipei

manufacturer

Authorised representative: Obelis s.a. (BE-AR-000000106)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/rooti-rx-0092 · UDI page: /udi/04719873370092

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