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Northern Digital Inc

Canada·CA-MF-000023503

Last updated May 30, 2026

Information

Country: Canada
Address: 103 , Randall Drive, Waterloo, Ontario, Canada
Website: www.ndigital.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 802-735-6995
PRRC Contact: Benjamin Breen
EUDAMED SRN: CA-MF-000023503
FDA FEI Number: —
DUNS Number: 241987692

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
Disposable Reflective Marker Spheres (DRMS)	41774	FDA UDI	Class II	Active
Disposable Reflective Marker Sphere (DRMS)	41773	FDA UDI	Class II	Active
NDI Passive Spheres	8801320	FDA UDI	Class II	Active
Disposable Reflective Marker Spheres (DRMS)	41813	FDA UDI	Class II	Active
Disposable Reflective Marker Sphere™	41813	EUDAMED	Class I	Active
8801051 NDI Sterile Passive Spheres; 1 sphere per tray; 12 trays per box. Total 12 spheres per box	8801051	EUDAMEDFDA UDI	Class I	Active
8801054 NDI Sterile Passive Spheres; 4 spheres per tray; 12 trays per box. Total 48 spheres per box	8801054	EUDAMEDFDA UDI	Class I	Active
8801320 NDI Sterile Passive Spheres; 10 spheres per tray; 2 trays per box. Total 20 spheres per box	8801320x	EUDAMED	Class I	Active
8801074 NDI Sterile Passive Markers - 4 spheres in tray 12 trays per box OEM 509	8801074	EUDAMEDFDA UDI	Class I	Active
8800737 NDI Sterile Passive Spheres; 1 sphere per pouch; 5 pouches per box. Total 5 spheres per box	8800737	EUDAMEDFDA UDI	Class I	Active
8800966 NDI Sterile Passive Spheres; 15 spheres per tray; 2 trays per box. Total 30 spheres per box	8800966	EUDAMEDFDA UDI	Class I	Active
8801053 NDI Sterile Passive Spheres; 3 spheres per tray; 12 trays per box. Total 36 spheres per box	8801053	EUDAMEDFDA UDI	Class I	Active
8800965 NDI Sterile Passive Spheres; 9 spheres per tray; 2 trays per box. Total 18 spheres per box	8800965	EUDAMEDFDA UDI	Class I	Active
8801075 NDI Sterile Passive Markers - 5 spheres in tray 12 trays per box OEM 509	8801075	EUDAMEDFDA UDI	Class I	Active
Disposable Reflective Marker Sphere™	41773	EUDAMED	Class I	Active
8801002 NDI Sterile Passive Spheres; 5 spheres per tray; 12 trays per box. Total 60 spheres per	8801002	EUDAMEDFDA UDI	Class I	Active
8801071 NDI Sterile Passive Markers - 1 sphere in tray 12 trays per box OEM 509	8801071	EUDAMEDFDA UDI	Class I	Active
41813 Disposable Reflective Marker Spheres; 2 spheres per tray; 30 trays per box. Total 60 spheres per box	41813	EUDAMED	Class I	Active
Disposable Reflective Marker Spheres	41773	EUDAMED	Class I	Active
8800739 NDI Sterile Passive Spheres; 4 spheres per pouch; 5 pouches per box. Total 20 spheres per box	8800739	EUDAMEDFDA UDI	Class I	Active
8801085 NDI Sterile Passive Markers - 5 spheres in tray 1 tray per box OEM 509	8801085	EUDAMEDFDA UDI	Class I	Active
8800738 NDI Sterile Passive Spheres; 3 spheres per pouch; 5 pouches per box. Total 15 spheres per box	8800738	EUDAMEDFDA UDI	Class I	Active
8800967 NDI Sterile Passive Spheres; 12 spheres per tray; 2 trays per box. Total 24 spheres per box	8800967	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

NDI Europe GmbH DE

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.