Unknown / Not in EUDAMED

Snapshot 2026-10-13 · Link to EUDAMED

Tap Ø4.5 mm, for 4.5 mm cannulated screws

UDI-DI 06438394005198Basic UDI-DI 6438394INS005WN

Class I · MDR · Bioretec Ltd.

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Identification

Model: —
EMDN: L098003
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

SRN FI-MF-000001328

FI · Tampere

manufacturer

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Tap Ø3.5 mm, for 3.5 mm cannulated screws 06438394005174
Tap Ø3.5 mm, for 3.5 mm screws 06438394001350
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Tap Ø4.5 mm, for 4.5 mm screws up to length 45 mm 06438394003248

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/activa-instrument-5198 · UDI page: /udi/06438394005198

All devices from Bioretec Ltd.

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