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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 1 of 4

Device	Model / Reference	Registries	Class	Status
Activa Instrument	B-II-1630B	EUDAMED	Class IIa	Active
Countersink for RemeOs™ Screw LAG 2.0/2.5 mm, quick coupling	B-IRC-2504L	EUDAMED	Class I	Active
ActivaScrew™ Interference TCP	15 - 30 °C	EUDAMED	Class III	Active
ActivaScrew™ Cannulated LAG	B-ALC-4540	EUDAMED	Class III	Active
Countersink for RemeOs™ Screw COM 3.0 mm, quick coupling	B-IRC-3004C	EUDAMED	Class I	Active
Activa Instrument	B-DIP-2000	EUDAMED	Class IIa	Active
ActivaScrew™ Cannulated LAG	B-ALC-3526	EUDAMED	Class III	Active
ActivaNail™ Conical	B-ANCO-2020	EUDAMED	Class III	Active
ActivaScrew™ Interference TCP	B-DI-1128	EUDAMED	Class III	Active
ActivaScrew™ Interference	B-AI-0930	EUDAMED	Class III	Active
Driver T8, for RemeOs™ Screw 3.0 mm, quick coupling	B-IRC-3002	EUDAMED	Class I	Active
Activa IM-Nail™	B-ANIM-32400	EUDAMED	Class III	Active
Activapin Ht, Fuse Link (private Labled For Footmind, Inc.)	K133950	FDA 510(k)	Class II	Active
RemeOs™ Screw LAG Solid	DEN220030	FDA 510(k)	Class II	Active
Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm Conicaltm	K080879	FDA 510(k)	Class II	Active
Bioretec Activascrew, Activascrew Cannulated And Activascrew Cannulated With Activapin	K081392	FDA 510(k)	Class II	Active
Activapin, Nexfix Rfs Pin, Nexfix Resorbable Fixation System (rfs)	K071863	FDA 510(k)	Class II	Active
ActivaScrew™ Cannulated	B-ASC-4060	EUDAMED	Class III	Active
Tap Ø 2.5 mm, for RemeOs™ Screw 2.5 mm	B-IRC-2501	EUDAMED	Class I	Active
Activa IM-Nail™	B-ANIM-32300	EUDAMED	Class III	Active
ActivaScrew™ Cannulated LAG	B-ALC-3545	EUDAMED	Class III	Active
Activa Instrument	B-IP-1504	EUDAMED	Class IIa	Active
ActivaScrew™ Cannulated	B-ASC-4080	EUDAMED	Class III	Active
Activa Instrument	B-ISC-4502	EUDAMED	Class I	Active
ActivaPin™	B-AP-3270	EUDAMED	Class III	Active
ActivaPin™	B-AP-1570	EUDAMED	Class III	Active
ActivaScrew™ Interference TCP	B-DI-0420	EUDAMED	Class III	Active
Activa Instrument	B-IP-1505	EUDAMED	Class IIa	Active
Sterilization Insert, for RemeOs™ Instruments	B-IRC-9001	EUDAMEDFDA UDI	Class I	Active
Activa Instrument	B-IS-9020	EUDAMED	Class I	Active
ActivaScrew™ Cannulated	B-ASC-4570	EUDAMED	Class III	Active
ActivaScrew™ Interference	B-AI-0928	EUDAMED	Class III	Active
Double drill sleeve Ø1.5/2.0 mm, for 2.0mm screws	B-IS-2005	EUDAMED	Class I	Active
ActivaScrew™ Cannulated	B-ASC-4580	EUDAMED	Class III	Active
Sterilisation tray, for ActivaPin™ instruments	B-IP-4003	EUDAMED	Class I	Active
Activa Instrument	B-IP-4001	EUDAMED	Class I	Active
Activa Instrument	B-IS-9012	EUDAMED	Class I	Active
Activa Instrument	B-IP-1501	EUDAMED	Class IIa	Active
Activa Instrument	B-IS-4500	EUDAMED	Class IIa	Active
HEX shaft, for 3.5 mm cannulated screws	B-ISC-9032	EUDAMED	Class I	Active
ActivaScrew™	B-AS-4550	EUDAMED	Class III	Active
Activa Instrument	B-IS-2705	EUDAMED	Class I	Active
ActivaNail™ Conical	B-ANCO-2015	EUDAMED	Class III	Active
Activa Instrument	B-ISC-4501	EUDAMED	Class IIa	Active
ActivaPin™	B-AP-1530	EUDAMED	Class III	Active
ActivaScrew™ Interference	B-AI-0510	EUDAMED	Class III	Active
Activa Instrument	B-ISC-3500	EUDAMED	Class IIa	Active
Countersink for RemeOs™ Screw FT 2.0 mm, quick coupling	B-IRC-2004FT	EUDAMED	Class I	Active
ActivaPin™	B-AP-1540	EUDAMED	Class III	Active
Sterilization Base and Lid, for Sterilization Inserts	B-IRC-9000	EUDAMEDFDA UDI	Class I	Active

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Bioretec Oy US