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Bioretec Ltd.

Finland·FI-MF-000001328

Last updated September 17, 2026

Information

Country: Finland
Address: 5, Yrittäjänkulma , Tampere, Finland
Website: www.bioretec.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Mari Ruotsalainen
EUDAMED SRN: FI-MF-000001328
FDA FEI Number: 3005536892
DUNS Number: —

Catalogue (177)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
ActivaScrew™ Interference	B-AI-0420	EUDAMED	Class III	Active
Activa Instrument	B-IP-2701	EUDAMED	Class IIa	Active
ActivaScrew™ Cannulated	B-ASC-3520	EUDAMED	Class III	Active
ActivaScrew™ Cannulated	B-ASC-3536	EUDAMED	Class III	Active
ActivaScrew™ Interference	B-AI-0620	EUDAMED	Class III	Active
ActivaScrew™ Cannulated	B-ASC-4065	EUDAMED	Class III	Active
Torx driver, for 7/8/9/10/11 mm interference screws	B-II-9031	EUDAMED	Class I	Active
ActivaScrew™ Cannulated LAG	B-ALC-4545	EUDAMED	Class III	Active
ActivaScrew™ Cannulated	B-ASC-4055	EUDAMED	Class III	Active
ActivaScrew™	B-AS-3536	EUDAMED	Class III	Active
ActivaScrew™ Interference TCP	B-DI-0930	EUDAMED	Class III	Active
Activa Instrument	B-IS-4511	EUDAMED	Class IIa	Active
ActivaScrew™	B-AS-4555	EUDAMED	Class III	Active
Tap Ø2.7 mm, for 2.7 mm screws	B-IS-2701	EUDAMED	Class I	Active
Activa Instrument	B-IS-9033	EUDAMED	Class I	Active
Activa Instrument	B-IP-2012	EUDAMED	Class I	Active
ActivaScrew™	B-AS-4570	EUDAMED	Class III	Active
Tap Ø 4.0 mm, for RemeOs™ Screw 4.0 mm	B-IRC-4001	EUDAMED	Class I	Active
Countersink for RemeOs™ Screw FT 3.0 mm, quick coupling	B-IRC-3004FT	EUDAMED	Class I	Active
ActivaScrew™ Interference	B-AI-1030	EUDAMED	Class III	Active
Activa Instrument	B-IP-4004	EUDAMED	Class I	Active
Applicator Ø2.0 mm, reusable, for 2.0 mm pins	B-IP-2000	EUDAMED	Class I	Active
Applicator tip, arthroscopic, for 1.5 mm pins	B-IP-1512	EUDAMED	Class I	Active
Activa Instrument	B-IS-6505	EUDAMED	Class I	Active
Driver T10, for RemeOs™ Screw 3.5/4.0 mm, quick coupling	B-IRC-4002	EUDAMEDFDA UDI	Class I	Active
Activa Instrument	B-ISC-4504	EUDAMED	Class IIa	Active
Activa Instrument	B-ISC-3502	EUDAMED	Class I	Active
Countersink for RemeOs™ Screw COM 3.5 mm, quick coupling	B-IRC-3504C	EUDAMED	Class I	Active
ActivaScrew™ Interference TCP	B-DI-0924	EUDAMED	Class III	Active
ActivaScrew™ Interference TCP	B-DI-0820	EUDAMED	Class III	Active
ActivaNail™ Conical	B-ANCO-1510	EUDAMED	Class III	Active
ActivaScrew™ Interference TCP	B-DI-0928	EUDAMED	Class III	Active
T-handle, quick coupling	B-IS-9010	EUDAMED	Class I	Active
Activa Instrument	B-II-5000	EUDAMED	Class IIa	Active
Applicator Ø1.5 mm, reusable, for 1.5 mm pins	B-IP-1500	EUDAMED	Class I	Active
Activa Instrument	B-ISC-3501	EUDAMED	Class IIa	Active
ActivaScrew™ Interference	B-AI-0824	EUDAMED	Class III	Active
Sterilization tray, for ActivaScrew™ Cannulated instruments	B-ISC-9000	EUDAMED	Class I	Active
Activa Instrument	B-IS-9032	EUDAMED	Class I	Active
Activa Instrument	B-II-0815B	EUDAMED	Class IIa	Active
Large handle, cannulated, quick coupling	B-ISC-9013	EUDAMED	Class I	Active
Countersink for RemeOs™ Screw FT 2.5 mm, quick coupling	B-IRC-2504FT	EUDAMED	Class I	Active
Countersink for RemeOs™ Screw LAG 3.0/3.5/4.0 mm, quick coupling	B-IRC-4004L	EUDAMED	Class I	Active
ActivaScrew™	B-AL-4550	EUDAMED	Class III	Active
Holding sleeve, for 2.0/2.7/3.5mm screws	B-IS-3503	EUDAMED	Class I	Active
ActivaPin™	B-AP-2750	EUDAMED	Class III	Active
Activa Instrument	B-II-9000	EUDAMED	Class I	Active
Depth gauge, for 4.5 mm screws	B-IS-9021	EUDAMED	Class I	Active
ActivaScrew™ Interference	B-AI-0828	EUDAMED	Class III	Active
Countersink for RemeOs™ Screw COM 4.0 mm, quick coupling	B-IRC-4004C	EUDAMED	Class I	Active

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Bioretec Oy US