Bioretec Ltd. devices, product family

by Bioretec Ltd. 8 variants Basic UDI-DI 6438394INS010WF

Shared by every variant

Manufacturer: Bioretec Ltd.(8)
Basic UDI-DI: 6438394INS010WF
Risk class: Class I
Legislation: MDDMDR (varies)
EMDN category: ORTHOPAEDIC SURGERY GUIDES, REUSABLE
Market status: 8 on the market
Official record: EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 6438394INS010WF.

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

0 recalls · FDA

No recall matched the devices on this page.

Recalls matched to the 8 devices listed on this page; other pages of the family can carry others.

8 devices · page 1 of 1

Variants of Bioretec Ltd. devices, Basic UDI-DI 6438394INS010WF
		UDI-DI	Size and differences
Activa Instrument	B-IP-4001 / B-IP-4001	06438394000438	—	On the market
Activa Instrument	B-IS-2705 / B-IS-2705	06438394001497	—	On the market
Activa Instrument	B-IS-3505 / B-IS-3505	06438394001503	—	On the market
Activa Instrument	B-IS-4505 / B-IS-4505	06438394001510	—	On the market
Activa Instrument	B-IS-6505 / B-IS-6505	06438394001527	—	On the market
Activa Instrument	B-ISC-3505 / B-ISC-3505	06438394005655	—	On the market
Activa Instrument	B-ISC-4505 / B-ISC-4505	06438394005662	—	On the market
Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws	B-IS-2005	06438394001480	—	On the market