No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

Swoop® Portable MR Imaging® System

UDI-DI 00850043319009Basic UDI-DI 0860000606100001R3

Class IIa · MDR · Hyperfine, Inc.

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Identification

Model: 850-11001-06 (900-11001-06, in crate)
EMDN: Z11050104
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

Hyperfine, Inc.

SRN US-MF-000029806

US · Guilford, CT

manufacturer

Authorised representative: Emergo Europe B.V. (NL-AR-000000116)

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All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/swoop-portable-mr-imaging-system-9009 · UDI page: /udi/00850043319009

All devices from Hyperfine, Inc.

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