Skip to content
UDI Compass
Certificate valid

Snapshot 2026-10-10 · Link to EUDAMED

SEAL™ ARC

UDI-DI 00850052512286Basic UDI-DI 0850052512SEALSV

Class III · MDR · Galaxy Therapeutics, Inc.

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
Yes
Measuring function
No
Reusable surgical
No
Certificates

1000322051

EU technical documentation assessment · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2026-07-29 · Expiry 2031-07-28

Scope not stated in certificate data.

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

1000269457

EU quality management system · valid

Notified body: DQS Medizinprodukte GmbH (0297)

Valid from 2026-07-29 · Expiry 2031-07-28

Scope not stated in certificate data.

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

Manufacturer

Galaxy Therapeutics, Inc.

SRN US-MF-000035675

US · Milpitas, California

manufacturer

Authorised representative: Specculo Limited (MT-AR-000034988)

Related UDI-DIs

Showing 12 of 13 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sealtm-arc-2286 · UDI page: /udi/00850052512286

Scan an inventory CSV