No Certificate Found

Snapshot 2026-10-12 · Link to EUDAMED

OuïeZen 12 GS BTE 13 UP

UDI-DI 00840388212288Basic UDI-DI 0842318163400UP

Class IIa · MDR · Starkey Laboratories Inc.

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Identification

Model: Behind-the-Ear (BTE)
EMDN: Y2145060101
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-12 · Link to EUDAMED

Manufacturer

Starkey Laboratories Inc.

SRN US-MF-000014382

US · Eden Prairie, Minnesota

manufacturer

Authorised representative: Starkey Laboratories (Germany) GmbH (DE-AR-000010831)

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AMPLI-POWER E 2|7S BTE-13P 00840388212219
AMPLI-POWER E 3|7S BTE-13M 00840388212608
AMPLI-POWER E 3|7S BTE-13P 00840388212202
AMPLI-POWER E 4|7S BTE-13M 00840388212783
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Showing 12 of 43 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/ouiezen-12-gs-bte-13-up-2288 · UDI page: /udi/00840388212288

All devices from Starkey Laboratories Inc.

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