No Certificate Found

Snapshot 2026-10-13 · Link to EUDAMED

Legacy device

Therapy Mask 3100 SP, fitpack, w/HGR, CE Silicone pillows

UDI-DI 00606959060043Basic UDI-DI B-00606959060043

Class IIa · MDD (legacy) · Respironics Inc.

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Identification

Model: 1145050
EMDN: R03010199
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/therapy-mask-3100-sp-fitpack-w-hgr-ce-silicone-pillows-0043 · UDI page: /udi/00606959060043

All devices from Respironics Inc.

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