Is this your brand? Sign in to claim ownership.

BRONCUS MEDICAL INC.

United States·US-MF-000027543

Last updated May 30, 2026

Information

Country: United States
Address: 125, Nicholson Lane, San Jose, United States
Website: www.broncus.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-877-428-1600
PRRC Contact: Antoinette Clay
EUDAMED SRN: US-MF-000027543
FDA FEI Number: —
DUNS Number: 078684808

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
BioStar Transbronchial Aspiration Needle	iS227	FDA UDI	Class II	Active
LungPoint Planning System, v3.2	30009	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-91-00	FDA UDI	Class II	Active
Archimedes Access Kit	10009-9	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-64-60	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-46-00	FDA UDI	Class II	Active
BioStar Transbronchial Aspiration Needle	iS237	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-82-00	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-82-70	FDA UDI	Class II	Active
Empower RF Catheter	10010	FDA UDI	Class II	Active
LungPoint VBN System, V3.2	30005	FDA UDI	Class II	Active
Archimedies Access Kit with Syringe	12196-09	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-46-55	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-91-55	FDA UDI	Class II	Active
BroncTru™ Transbronchial Access Tool	AK-64-00	FDA UDI	Class II	Active
Archimedes Access Key	10009-1	FDA UDI	Class II	Active
Archimedes Access Key, 10-pack	10009-2	FDA UDI	Class II	Active
Archimedes Access Kit	10009	EUDAMEDFDA UDI	Class IIa	Active
FleXNeedle® Transbronchial Aspiration Needle	10005-1	EUDAMEDFDA UDI	Class IIa	Active
Archimedes® System	40009	EUDAMEDFDA UDI	Class IIa	Active
BroncTru™ Transbronchial Access Tool	K232601	FDA 510(k)	Class II	Active
Lungpoint Atv Planning And Navigation Software	K133385	FDA 510(k)	Class II	Active
Lungpoint Tools (lungpoint Sheath, Lungpoint Dilation Balloon)	K131234	FDA 510(k)	Class II	Active
LungPoint Virtual Bronchoscopic Navigation (VBN) Software	K260009	FDA 510(k)	Class II	Active
BioStar Single Use Transbronchial Aspiration Needle	K232038	FDA 510(k)	Class II	Active
Empower RF Catheter	K183240	FDA 510(k)	Class II	Active
Archimedes Sheath	10007	EUDAMEDFDA UDI	Class IIa	Active
Archimedes® Lite	42005	EUDAMED	Class IIa	Active
FleXNeedle® Transbronchial Aspiration Needle	10005-2	EUDAMEDFDA UDI	Class IIa	Active
Archimedes® System	40005	EUDAMEDFDA UDI	Class IIa	Active
Archimedes® System	42105	EUDAMED	Class IIa	Active
Archimedes Dilation Balloon	10008	EUDAMEDFDA UDI	Class IIa	Active
EasyPath® RF Introducer Sheath	10011	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

MedDevConsult GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.