Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

MAX Elite Electrometer

UDI-DI 00850019946628Basic UDI-DI 0850019946ELECTROMETER7L

Class Im · MDR · Standard Imaging, Inc.

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Identification

Model: —
EMDN: Z11019082
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: Yes
Reusable surgical: No

Certificates

28620136130-01

EU quality management system · valid

Notified body: Intertek Medical Notified Body AB (2862)

Valid from 2023-02-22 · Expiry 2027-10-18

Scope not stated in certificate data.

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

Manufacturer

Standard Imaging, Inc.

SRN US-MF-000009855

US · Middleton

manufacturer

Authorised representative: Hoff & Lowendahl AB (SE-AR-000001888)

Related UDI-DIs

Max 4000 Plus Electrometer 00850019946086
SuperMAX 00850019946093
TomoElectrometer 00850019946222

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/max-elite-electrometer-6628 · UDI page: /udi/00850019946628

All devices from Standard Imaging, Inc.

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