13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Sweden
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Fujirebio Diagnostics AB
Manufacturer
🇸🇪 Sweden·TÜV Rheinland LGA Products GmbH
NuvoAir AB
Manufacturer
🇸🇪 Sweden·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY
Tietoevry AB
Manufacturer
🇸🇪 Sweden·2 Basic UDI-DIs·2 Devices·Eurofins Electric & Electronics Finland Oy
Tietoevry Sweden AB
Manufacturer
🇸🇪 Sweden·1 Basic UDI-DI·2 Devices·Eurofins Electric & Electronics Finland Oy
PulseLavage AB
Manufacturer
🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and Eurofins Electric & Electronics Finland Oy
QMT-Tech ab
System producer
🇸🇪 Sweden
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
CR-03-1228-849-24
Certificate
MDR QMS·Tietoevry AB·Eurofins Electric & Electronics Finland Oy
CR-03-1231-829-23
Certificate
MDR QMS·Tietoevry Sweden AB·Eurofins Electric & Electronics Finland Oy
FI23/00000051
Certificate
MDR QMS·NuvoAir AB·SGS FIMKO OY
HX 1060415-1
Certificate
IVDR QMS·Fujirebio Diagnostics AB·TÜV Rheinland LGA Products GmbH
M.2023.MDR.1013
Certificate
MDR QMS·PulseLavage AB·UDEM Adriatic d.o.o.
Intertek Medical Notified Body AB
Notified body
🇸🇪 Sweden·12 Manufacturers·2 Basic UDI-DIs