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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-09 · Link to EUDAMED

SavvyWire

UDI-DI 07540184030026Basic UDI-DI 07540184F3000ZW

Class III · MDR · Opsens Inc.

Identification
Model
F3001
EMDN
C0499
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

MDR 768042

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-09-14 · Expiry 2029-04-09

Scope not stated in certificate data.

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

Manufacturer

Opsens Inc.

SRN CA-MF-000018361

CA · Quebec

manufacturer

Authorised representative: MDSS GmbH (DE-AR-000005430)

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/savvywire-0026 · UDI page: /udi/07540184030026

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