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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

HiRes™ Ultra BTE Template

UDI-DI 00840094499621Basic UDI-DI 08400944CI4421XQ

Class III · MDR · Advanced Bionics LLC

Identification
Model
—
EMDN
J0380
Issuing agency
GS1
Device status
active
Sterile
No
Implantable
No
Measuring function
No
Reusable surgical
Yes
Certificates

G70 077725 0026

EU technical documentation assessment · unknown

Notified body: TÜV SÜD Product Service GmbH (0123)

Valid from 2026-06-29 · Expiry 2027-09-21

Scope not stated in certificate data.

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

Manufacturer

Advanced Bionics LLC

SRN US-MF-000019344

US · Valencia

manufacturer

Authorised representative: Advanced Bionics Logistic Services GmbH (DE-AR-000056289)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/hirestm-ultra-bte-template-9621 · UDI page: /udi/00840094499621

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