9 results
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16ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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Limbus AI Inc.
Manufacturer
🇨🇦 Canada·Kiwa Dare B.V.
SmileSonica Inc.
Manufacturer
🇨🇦 Canada·Intertek Medical Notified Body AB
Epocal Inc.
Manufacturer
🇨🇦 Canada·2 Importers·TÜV Rheinland LGA Products GmbH
Dominion Biologicals Limited
Manufacturer
🇨🇦 Canada·TÜV Rheinland LGA Products GmbH
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
HX 1804155-1
Certificate
IVDR QMS·Dominion Biologicals Limited·TÜV Rheinland LGA Products GmbH
21M00123CRT01
Certificate
MDR QMS·Limbus AI Inc.·Kiwa Dare B.V.
28620156455
Certificate
MDR QMS·SmileSonica Inc.·Intertek Medical Notified Body AB
HX 2262557-1
Certificate
IVDR QMS·Epocal Inc.·TÜV Rheinland LGA Products GmbH