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Snapshot 2026-10-13 · Link to EUDAMED

Legacy device

Large Amara Gel Mask with Reduced Size Frame and Headgear International

UDI-DI 00606959021181Basic UDI-DI B-00606959021181

Class IIa · MDD (legacy) · Respironics Inc.

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Identification

Model: Amara Gel SE
EMDN: R0301010202
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Manufacturer

Respironics Inc.

SRN US-MF-000002301

US · Murrysville

manufacturer

Authorised representative: Respironics Deutschland GmbH & Co.KG (DE-AR-000006164)

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/large-amara-gel-mask-with-reduced-size-frame-and-headgear-in-1181 · UDI page: /udi/00606959021181

All devices from Respironics Inc.

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