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 400 Series - 05902533511440 Catalog Number : 4SSAUPHRAAAA

Device Description : Steam Sterilizer – 433HC-E,L1,SD,208 VPS BRASS,DU,PWR,R+2,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 700 Series - 05902533511457 Catalog Number : 7MERUPHTAAAA

Device Description : STEAM STERILIZER - 733HC-E,L2,DDLHRH,208 VPS SST,DU,PWR,TRK,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 700 Series - 05902533511464 Catalog Number : 7SLRUPHTAAAA

Device Description : STEAM STERILIZER - 733HC-E,L1,SDLH,208 VPS SST,DU,PWR,TRK,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511471 Catalog Number : 5SSAUMHRATAA

Device Description : Steam Sterilizer – 533HC-E,L1,SD,208 VPS BRASS,DU,MAN,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 - 05902533511488 Catalog Number : 5SSAUPHRATAA

Device Description : Steam Sterilizer – 533HC-E,L1,SD,208 VPS BRASS,DU,PWR,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 - 05902533511495 Catalog Number : 5SSAUMHRAAAA

Device Description : Steam Sterilizer – 533HC-E,L1,SD,208 VPS BRASS,DU,MAN,R+2,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511501 Catalog Number : 5SDAUPHRAAAA

Device Description : Steam Sterilizer – 533HC-E,L1,DD,208 VPS BRASS,DU,PWR,R+2,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511518 Catalog Number : 5SSVUMHTTWAA

Device Description : Steam Sterilizer – 533HC-E,L1,SD,EJ,DU,MAN,TRK,REC/TF,380

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 400 Series - 05902533511525 Catalog Number : 4SSVUPHRA3AA

Device Description : Steam sterilizer - 433HC-E,L1,SD,EJ,DU,PWR,R+2,REC,380/BD

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511532 Catalog Number : 8SEVUGHPTAAA

Device Description : STEAM STERILIZER - 833HC-E,L1,DDLHRH,DU,PFM,RLR,REC/TF

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

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