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Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Applicator Ø3.2 mm, reusable, for 3.2 mm pins and for 1.5/2.0/2.7/3.2 mm nails

UDI-DI 06438394000254Basic UDI-DI 6438394INS007WS

Class I · MDR · Bioretec Ltd.

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

2250004CE01

EU quality management system · unknown

Notified body: DEKRA Certification B.V. (0344)

Valid from 2026-09-04 · Expiry 2027-10-01

Scope not stated in certificate data.

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

Manufacturer

Bioretec Ltd.

SRN FI-MF-000001328

FI · Tampere

manufacturer

Related UDI-DIs

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/activa-instrument-0254 · UDI page: /udi/06438394000254

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