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Umano Medical Inc

Canada·CA-MF-000015592

Last updated September 17, 2026

Information

Country: Canada
Address: 230, boulevard Nilus-Leclerc, L'Islet, Canada
Website: www.umanomedical.com/en-ca/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 418-247-3986
PRRC Contact: Benoit Leclerc
EUDAMED SRN: CA-MF-000015592
FDA FEI Number: 3009591865
DUNS Number: 249675476

Catalogue (92)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Florence bed	FL23SE	FDA UDI	Class II	Unknown
ook snow ALL	200-0000	FDA UDI	Class II	Active
airNEST orange	USTAOS-803508N-CT-BIL	FDA UDI	Class II	Active
ook snow MH	FL36 ook snow MH	FDA UDI	Class II	Active
ook snow MH	FL36 ook snow MH	FDA UDI	Class II	Active
ook snow ALL	200-0000	FDA UDI	Class II	Active
ook cocoon	FL36 ook cocoon	FDA UDI	Class II	Active
airNEST orange HYBRID	USTAOHYBS-803507D-CT-BIL	FDA UDI	Class II	Active
Manual Bed	FL23SM	FDA UDI	Class I	Unknown
Umano Connect	282-0002	FDA UDI	Class II	Active
airNEST orange	USTAOS-843508D-BIL	FDA UDI	Class II	Active
ook snow MH	FL36 ook snow MH	FDA UDI	Class II	Active
ook cocoon	FL36 ook cocoon	FDA UDI	Class II	Active
airNEST orange HYBRID	USTAOHYBS-803507D-BIL	FDA UDI	Class II	Active
ook snow	FL36 ook snow	FDA UDI	Class II	Active
ook snow MH	FL36 ook snow MH	FDA UDI	Class II	Active
airNEST orange	USTAOS-843508N-CT-BIL	FDA UDI	Class II	Active
Freedom 1000	FM1000	FDA UDI	Class II	Unknown
ook cocoon	FL36 ook cocoon	FDA UDI	Class II	Unknown
Freedom 500	FM500	FDA UDI	Class II	Unknown
airNEST orange HYBRID	USTAOHYBS-843507N-CT-BIL	FDA UDI	Class II	Active
airNEST orange	USTAOS-803508D-BIL	FDA UDI	Class II	Active
Patient Helper	FA64504WG-TRI	EUDAMEDFDA UDI	Class I	Active
Removable Patient Control – 6 Functions	299-0151-TRI	EUDAMEDFDA UDI	Class I	Active
Right 1’’ Folding Iv Pole For 1’’ Socket	FA64523-TRI	EUDAMEDFDA UDI	Class I	Active
Umano Connect	282-0002	EUDAMED	Class I	Active
Ook Snow, Ook Snow Mh	FL36-SC	EUDAMED	Class I	Active
oneNEST S	303-843508HS4FB-BIL	EUDAMEDFDA UDI	Class I	Active
UmanoLocation	284-0000-TRI	EUDAMEDFDA UDI	Class I	Active
1’’ Fixed Iv Pole For 3/4’’ Socket	FA64522-TRI	EUDAMEDFDA UDI	Class I	Active
1’’ Fixed Iv Pole For 1’’ Socket	FA64508-TRI	EUDAMEDFDA UDI	Class I	Active
Removable Patient Control – 5 Functions	FA64510-TRI	EUDAMEDFDA UDI	Class I	Active
Folding Iv Pole ¾’’	FA64507-TRI	EUDAMEDFDA UDI	Class I	Active
Removable Patient Control – 2 Functions	FA64511-TRI	EUDAMEDFDA UDI	Class I	Active
Ook Snow All	200-0000	EUDAMEDFDA UDI	Class I	Active
oneNEST S	303-803508HS4FB-BIL	EUDAMEDFDA UDI	Class I	Active
Fixed Iv Pole ¾’’	FA64506-TRI	EUDAMEDFDA UDI	Class I	Active
Removable Patient Control – 2 Functions	FA64509-TRI	EUDAMEDFDA UDI	Class I	Active
Removable Patient Control – 5 Functions	299-0152-TRI	EUDAMEDFDA UDI	Class I	Active
Left 1’’ Folding Iv Pole For 1’’ Socket	FA64521-TRI	EUDAMEDFDA UDI	Class I	Active
Transport Shelf	299-0523WG-TRI	EUDAMEDFDA UDI	Class I	Active
Patient Helper	299-0100WG-TRI	EUDAMEDFDA UDI	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 Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 11, 2022	Z-1135-2022	—	terminated	There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.
Apr 11, 2022	Z-1136-2022	—	terminated	There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.
May 4, 2020	Z-2205-2020	—	terminated	Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.