Is this your brand? Sign in to claim ownership.

Bioncise NV

Belgium·BE-MF-000000875

Last updated September 17, 2026

Information

Country: Belgium
Address: 16, Bodemstraat, Wellen, Belgium
Website: www.bioncise.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +3211271557
PRRC Contact: Jaak Janssens
EUDAMED SRN: BE-MF-000000875
FDA FEI Number: 3007513241
DUNS Number: —

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
Spirotome SS‐08‐MR	05407005001165	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐10‐15	05407005001073	EUDAMEDFDA UDI	Class IIa	Active
Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix	K190378	FDA 510(k)	Class II	Active
Spirotome Endo	SS-14-EN1	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐10‐06	05407005001103	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐10‐08	05407005001097	EUDAMEDFDA UDI	Class IIa	Active
Spirotome Bone	SS-10-BO	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐08-MR	05407005001158	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐14‐15	05407005001110	EUDAMEDFDA UDI	Class IIa	Active
Spirotome Endo	SS-10-EN	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐14-06	05407005001141	EUDAMEDFDA UDI	Class IIa	Active
Spirotome	SS-08-CE	EUDAMEDFDA UDI	Class IIa	Active
Spirotome Bone	SS-08-BO	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐14‐10	05407005001127	EUDAMEDFDA UDI	Class IIa	Active
Spirotome Cervicore	SS-08*EN	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐10‐20	05407005001066	EUDAMEDFDA UDI	Class IIa	Active
Spirotome Endo	SS-08-EN	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐10‐10	05407005001080	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐08‐06	05407005001059	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐08‐20	05407005001011	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐14‐08	05407005001134	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐08‐08	05407005001042	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐08‐10	05407005001035	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐19-FL	05407005001295	EUDAMED	Class IIa	Active
Spirotome Endo	SS-14-EN	EUDAMEDFDA UDI	Class IIa	Active
Spirotome SS‐16-FL	05407005001301	EUDAMED	Class IIa	Active
Spirotome SS‐08‐15	05407005001028	EUDAMEDFDA UDI	Class IIa	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.

Bioncise US