Is this your brand? Sign in to claim ownership.

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 2 of 4

Device	Model / Reference	Registries	Class	Status
ActivaScrew™ Cannulated LAG	B-ALC-4560	EUDAMED	Class III	Active
Activa Instrument	B-IP-3203	EUDAMED	Class IIa	Active
Tap Ø 3.0 mm, for RemeOs™ Screw 3.0 mm	B-IRC-3001	EUDAMED	Class I	Active
Activa Instrument	B-IP-4000	EUDAMED	Class I	Active
ActivaScrew™ Cannulated	B-ASC-4040	EUDAMED	Class III	Active
Activa Instrument	B-ISC-1250	EUDAMED	Class IIa	Active
Activa IM-Nail™	B-ANIM-20200	EUDAMED	Class III	Active
Activa Instrument	B-IP-3200	EUDAMED	Class I	Active
Tap Ø 3.5 mm, for RemeOs™ Screw 3.5 mm	B-IRC-3501	EUDAMED	Class I	Active
ActivaScrew™ Interference	B-AI-0720	EUDAMED	Class III	Active
Activa Instrument	B-II-9032	EUDAMED	Class I	Active
Activa Instrument	B-II-1624	EUDAMED	Class IIa	Active
ActivaScrew™ Interference TCP	B-DI-0824	EUDAMED	Class III	Active
Activa Instrument	B-IS-2000	EUDAMED	Class IIa	Active
Activa IM-Nail™	B-ANIM-27300	EUDAMED	Class III	Active
ActivaScrew™ Interference	B-AI-1028	EUDAMED	Class III	Active
Inserter for intramedullary nail	B-INIM-4000	EUDAMED	Class I	Active
Activa Instrument	B-IS-4505	EUDAMED	Class I	Active
ActivaScrew™ Interference	B-AI-0410	EUDAMED	Class III	Active
ActivaScrew™	B-AS-3540	EUDAMED	Class III	Active
Applicator Ø2.7 mm, reusable, for 2.7 mm pins	B-IP-2700	EUDAMED	Class I	Active
Countersink for RemeOs™ Screw FT 3.5 mm, quick coupling	B-IRC-3504FT	EUDAMED	Class I	Active
Activa Instrument	B-IS-3501	EUDAMED	Class IIa	Active
Applicator tip, arthroscopic, for 1.5/2.0 mm nails	B-IP-3212	EUDAMED	Class I	Active
ActivaScrew™	B-AS-3532	EUDAMED	Class III	Active
Sterilization tray, for ActivaNail™ 1.5/2.0mm	B-IP-4006	EUDAMED	Class I	Active
ActivaScrew™ Cannulated LAG	B-ALC-4045	EUDAMED	Class III	Active
Holding sleeve, for 4.0/4.5mm cannulated screws	B-ISC-4503	EUDAMED	Class I	Active
ActivaScrew™ Interference TCP	B-DI-0720	EUDAMED	Class III	Active
Countersink, for 2.0 mm screws	B-IS-2004	EUDAMED	Class I	Active
Activa Instrument	B-ISC-3505	EUDAMED	Class I	Active
ActivaScrew™ Cannulated LAG	B-ALC-3540	EUDAMED	Class III	Active
ActivaScrew™ Cannulated LAG	B-ALC-4080	EUDAMED	Class III	Active
Activa Instrument	B-IIS-1000	EUDAMED	Class IIa	Active
ActivaScrew™ Interference	B-AI-0920	EUDAMED	Class III	Active
Activa Instrument	B-IS-9000	EUDAMED	Class I	Active
Activa Instrument	B-IS-2001	EUDAMED	Class IIa	Active
ActivaScrew™	B-AL-3540	EUDAMED	Class III	Active
ActivaScrew™ Interference	B-AI-0924	EUDAMED	Class III	Active
Activa Instrument	B-IS-4501	EUDAMED	Class IIa	Active
Activa Instrument	B-IS-4504	EUDAMED	Class IIa	Active
Driver T6, for RemeOs™ Screw 2.0/2.5 mm, quick coupling	B-IRC-2502	EUDAMED	Class I	Active
Holding sleeve, for 4.5mm screws	B-IS-4503	EUDAMED	Class I	Active
Dilator for 3.2 mm intramedullary nail	B-INIM-3200	EUDAMED	Class I	Active
ActivaNail™ Conical	B-ANCO-2025	EUDAMED	Class III	Active
ActivaScrew™ Interference	B-AI-0415	EUDAMED	Class III	Active
ActivaScrew™	B-AL-3530	EUDAMED	Class III	Active
Activa Instrument	B-ISC-9020	EUDAMED	Class I	Active
ActivaNail™ Conical	B-ANCO-1525	EUDAMED	Class III	Active
ActivaScrew™ Interference TCP	B-DI-0833	EUDAMED	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Bioretec Oy US