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Bioretec Ltd. devices, product family

by Bioretec Ltd. 12 variants Basic UDI-DI 6438394INS005WN

Shared by every variant

Manufacturer
Bioretec Ltd.(12)
Basic UDI-DI
6438394INS005WN
Risk class
Class IClass IIa (varies)
Legislation
MDDMDR (varies)
EMDN category
ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE
Market status
12 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 6438394INS005WN.

Certificates

1 certificate naming this Basic UDI-DI · EUDAMED

  • 2250004CE01 Quality management system · refdata.applicable-legislation.mdr amended
    Notified body 0344 · holder Bioretec Ltd. · issued 4 Sep 2026 · expires 1 Oct 2027

Recalls

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 12 devices listed on this page; other pages of the family can carry others.

Variants

12 devices · page 1 of 1

Variants of Bioretec Ltd. devices, Basic UDI-DI 6438394INS005WN
UDI-DISize and differences
Activa Instrument B-IS-2001 / B-IS-200106438394001336 —On the market
Activa Instrument B-IS-3501 / B-IS-350106438394001350 —On the market
Activa Instrument B-IS-4501 / B-IS-450106438394001367 —On the market
Activa Instrument B-IS-4511 / B-IS-451106438394003248 —On the market
Activa Instrument B-ISC-3501 / B-ISC-350106438394005174 —On the market
Activa Instrument B-ISC-4501 / B-ISC-450106438394005198 —On the market
Tap Ø 2.5 mm, for RemeOs™ Screw 2.5 mm B-IRC-250106438394013261 —On the market
Tap Ø 3.0 mm, for RemeOs™ Screw 3.0 mm B-IRC-300106438394013278 —On the market
Tap Ø 3.5 mm, for RemeOs™ Screw 3.5 mm B-IRC-350106438394013285 —On the market
Tap Ø 4.0 mm, for RemeOs™ Screw 4.0 mm B-IRC-400106438394013292 —On the market
Tap Ø2.7 mm, for 2.7 mm screws B-IS-270106438394001343 —On the market
Tap Ø4.0 mm, for 4.0 mm cannulated screws B-ISC-400106438394005181 —On the market