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UDI Compass

Sterilization tray, for ActivaNail™ 1.5/2.0mm

Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 06438394011434Basic UDI-DI 6438394INS015WR

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Class I · MDR · Bioretec Ltd.

Identification

Model
—
Issuing agency
GS1
Device status
discontinued
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

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Unknown / Not in EUDAMED

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Sterilization Base and Lid, for Sterilization Inserts06438394015760
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Sterilization Insert, for RemeOs™ Instruments06438394015777
Unknown / Not in EUDAMED

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Sterilization tray, for ActivaScrew™ Cannulated instruments06438394005679
Unknown / Not in EUDAMED

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Sterilization tray, for ActivaScrew™ instruments06438394001558
Unknown / Not in EUDAMED

Snapshot 2026-11-02 · Link to EUDAMED

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/sterilization-tray-for-activanailtm-1-5-2-0mm-1434 · UDI page: /udi/06438394011434

All devices from Bioretec Ltd.