Bioretec Ltd. devices, product family

by Bioretec Ltd. 8 variants Basic UDI-DI 6438394INS007WS

Shared by every variant

Manufacturer: Bioretec Ltd.(8)
Basic UDI-DI: 6438394INS007WS
Risk class: Class I
Legislation: MDRMDD (varies)
EMDN category: OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES
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 6438394INS007WS.

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 6438394INS007WS
		UDI-DI	Size and differences
Activa Instrument	B-IP-2012 / B-IP-2012	06438394002395	—	On the market
Activa Instrument	B-IP-3200 / B-IP-3200	06438394000254	—	On the market
Activa Instrument	B-IP-4004 / B-IP-4004	06438394005280	—	On the market
Applicator tip, arthroscopic, for 1.5 mm pins	B-IP-1512	06438394002456	—	On the market
Applicator tip, arthroscopic, for 1.5/2.0 mm nails	B-IP-3212	06438394002531	—	On the market
Applicator Ø1.5 mm, reusable, for 1.5 mm pins	B-IP-1500	06438394000223	—	On the market
Applicator Ø2.0 mm, reusable, for 2.0 mm pins	B-IP-2000	06438394000230	—	On the market
Applicator Ø2.7 mm, reusable, for 2.7 mm pins	B-IP-2700	06438394000247	—	On the market