GETINGE IC PRODUCTION POLAND SP Z O O

Address:Szkolna 30,Plewiska Wielkopolskie,PL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Sterilizer, Steam (FLE) (10)

Premarket Exempt

Clear

Getinge 500 Series - 05902533511754 Catalog Number : 5SDVUMHTTAAA

Device Description : Steam Sterilizer – 533HC-E,L1,DD,EJ,DU,MAN,HC,TRK,REC/TF

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511761 Catalog Number : 8SRPUTHPAAAA

Device Description : STEAM STERILIZER - 833HC-E,L1,SDRH,EJ-SST,DU,PPM,HC,RLR,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511778 Catalog Number : 8SLPUTHPAAAA

Device Description : STEAM STERILIZER - 833HC-E,L1,SDLH,EJ-SST,DU,PPM,HC,RLR,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511785 Catalog Number : 5SDPUMHRAAAA

Device Description : Steam Sterilizer - 533HC-E,L1,DD,EJ-SST,DU,MAN,R+2,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511792 Catalog Number : 8SFPRTHPAAAA

Device Description : Steam Sterilizer - 833HC-E,L1,DD,EJ-SST,DU/PR,PPM,RLR,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511808 Catalog Number : 8SEPRTHPAAAA

Device Description : Steam Sterilizer - 833HC-E,L1,DD,EJ-SST,DU/PR,PPM,RLR,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511815 Catalog Number : 5SDVUPARATAA

Device Description : Steam Sterilizer - 533HC-E,L1,DD,EJ,DU,PWR,HCS,R+2.REC,208

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511822 Catalog Number : 5SSUUPHTAKAA

Device Description : Steam Sterilizer - 533HC-E,L1,SD,460 VPS SST,DU,PWR,TRK,REC,460/BD SST

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511839 Catalog Number : 5SSVUPHRA5AA

Device Description : Steam Sterilizer - 533HC-E,L1,SD,EJ,DU,PWR,HC,R2,REC,600/BD,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 700 Series - 05902533511853 Catalog Number : 7MRRUPHRAAAA

Device Description : Steam Sterilizer – 733HC-E,L2,SDRH,208 VPS SST,DU,PWR,R+3,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

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