SubtlePET (Software as a Service for post-processing of Positron Emission Tomography data)

Name: SubtlePET (Software as a Service for post-processing of Positron Emission Tomography data)
Brand: Subtle Medical, Inc.
SKU: 00860000171205

UDI-DI 00860000171205Basic UDI-DI 08600001712SubtlePET2B3

Class IIa · MDR · Subtle Medical, Inc.

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Identification

Model: 2.x
EMDN: Z11030582
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

28620157147

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2023-10-10 · Expiry 2028-07-14

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Subtle Medical, Inc.

SRN US-MF-000032747

US · Menlo Park

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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/subtlepet-software-as-a-service-for-post-processing-of-posit-1205 · UDI page: /udi/00860000171205

All devices from Subtle Medical, Inc.

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