No Certificate Found

Snapshot 2026-10-13 · Link to EUDAMED

SQA Phantom (MRI Quality Assurance Phantom)

UDI-DI 00860000606134Basic UDI-DI 0860000606100003R7

Class I · MDR · Hyperfine, Inc.

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Identification

Model: 810-11049-01
EMDN: Z1105018099
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-13 · Link to EUDAMED

Manufacturer

Hyperfine, Inc.

SRN US-MF-000029806

US · Guilford, CT

manufacturer

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

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/sqa-phantom-mri-quality-assurance-phantom-6134 · UDI page: /udi/00860000606134

All devices from Hyperfine, Inc.

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