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TRUDELL MEDICAL INTERNATIONAL

Canada·CA-MF-000009860

Last updated September 17, 2026

Information

Country: Canada
Address: 725, Baransway Drive, London, Canada
Website: www.trudellmed.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 519-455-4862
PRRC Contact: Marianne Tanton
EUDAMED SRN: CA-MF-000009860
FDA FEI Number: 3001610754
DUNS Number: —

Catalogue (45)

Device	Model / Reference	Registries	Class	Status
Comfortseal*	105502/105502110010	EUDAMED	Class I	Active
VersaPAP Positive Airway Pressure (PAP) Device	K173918	FDA 510(k)	Class II	Active
Corrugated tube with mouthpiece accessory	K203400	FDA 510(k)	Class II	Active
AeroChamber2go Anti-Static Valved Holding Chamber	K242667	FDA 510(k)	Class II	Active
MC 300R* Nebulizer	K173825	FDA 510(k)	Class II	Active
MC 300* Nebulizer	K173367	FDA 510(k)	Class II	Active
AeroEclipse* ONE BAN	K200063	FDA 510(k)	Class II	Active
Combined Aerobika OPEP and VersaPAP device	K183108	FDA 510(k)	Class II	Active
Aerochamber Plus Flow-Vu	108501/108501109060	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108508/108508109035	EUDAMED	Class I	Active
AeroChamber*	85851	EUDAMED	Class I	Active
Aerobika	110502/11050291001	EUDAMED	Class I	Active
AeroEclipse* BAN*	115503/115503110025	EUDAMEDFDA UDI	Class I	Active
AeroChamber Plus*	101501	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108504/108504115050	EUDAMED	Class I	Active
AeroChamber Plus* FlowVu*	108504/10850483035	EUDAMED	Class I	Active
Aerobika	110501 110502/11050491010	EUDAMEDFDA UDI	Class I	Active
Ombra*	105511	EUDAMED	Class IIa	Active
Aerochamber Plus Flow-Vu	108507/108507115070	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108501/10850182050	EUDAMED	Class I	Active
Aerochamber Plus	101501 / 101501100070	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108504/108504110035	EUDAMED	Class I	Active
Aerobika	110501	EUDAMEDFDA 510(k)	Class I	Active
Comfortseal*	105503/105503110010	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108508/108508117050	EUDAMED	Class I	Active
Aerochamber2go*	123501/123501126060	EUDAMED	Class I	Active
Smart Spacer	124501/12450191024	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108502/108502114070	EUDAMED	Class I	Active
AeroChamber Plus* FlowVu*	108507/10850783070	EUDAMED	Class I	Active
AeroTrach Plus*	101505	EUDAMEDFDA UDI	Class I	Active
Aerochamber Plus Flow-Vu	108501/108501115050	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108509/108509109060	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108504/108504109035	EUDAMED	Class I	Active
AeroChamber2go*	123501	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108507/108507117080	EUDAMED	Class I	Active
Comfortseal*	105504/105504110010	EUDAMED	Class I	Active
Ombra*	105515	EUDAMED	Class IIa	Active
AeroChamber Plus* FlowVu*	108502/10850283070	EUDAMED	Class I	Active
AeroChamber Plus*	101502	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108507/108507115080	EUDAMED	Class I	Active
RespiChamber*	113557/113557110050	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108501/108501117050	EUDAMED	Class I	Active
Aerochamber Plus Flow-Vu	108502/108502109070	EUDAMED	Class I	Active
Aerochamber2go*	123501/123501127060	EUDAMED	Class I	Active
AeroChamber Plus*	101502	EUDAMEDFDA 510(k)	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

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.

Trudell Medical International US