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Bioretec Ltd. devices, product family

by Bioretec Ltd. 7 variants Basic UDI-DI 6438394INS015WR

Shared by every variant

Manufacturer
Bioretec Ltd.(7)
Basic UDI-DI
6438394INS015WR
Risk class
Class I
Legislation
MDRMDD (varies)
EMDN category
TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS
Market status
6 on the market1 no longer on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 6438394INS015WR.

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 7 devices listed on this page; other pages of the family can carry others.

Variants

7 devices · page 1 of 1

Variants of Bioretec Ltd. devices, Basic UDI-DI 6438394INS015WR
UDI-DISize and differences
Activa Instrument B-II-9000 / B-II-900006438394011281 —On the market
Activa Instrument B-IS-9000 / B-IS-900006438394001558 —On the market
Sterilisation tray, for ActivaPin™ instruments B-IP-400306438394000445 —On the market
Sterilization Base and Lid, for Sterilization Inserts B-IRC-900006438394015760 —On the market
Sterilization Insert, for RemeOs™ Instruments B-IRC-900106438394015777 —On the market
Sterilization tray, for ActivaNail™ 1.5/2.0mm B-IP-400606438394011434 —No longer on the market
Sterilization tray, for ActivaScrew™ Cannulated instruments B-ISC-900006438394005679 —On the market