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 700 Series - 05902533511648 Catalog Number : 7MLVLPHTAAAA

Device Description : 733HC-E,L2,SDLH,EJ, LST,PWR,HC,TRK,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511655 Catalog Number : 5SDVUMHTTWAA

Device Description : Steam Sterilizer – 533HC-E,L1,DD,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 500 Series - 05902533511662 Catalog Number : 5SSPUPHTAAAA

Device Description : Steam Sterilizer – 533HC-E,L1,SD,EJ-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 - 05902533511686 Catalog Number : 7LFPUPHTAAAA

Device Description : 733HC-E,L3,DD,EJ-SST,DU,PWR,HC,TRK,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511693 Catalog Number : 8SEVUTCPAAAA

Device Description : STEAM STERILIZER - 833HC-E,L1,DD(LHRH),EJ,DU,HCF,RLR,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511709 Catalog Number : 8SFVUTCPAAAA

Device Description : STEAM STERILIZER - 833HC-E,L1,DD(LHRH),EJ,DU,HCF,RLR,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 800 Series - 05902533511716 Catalog Number : 8MFPUGHPAAAA

Device Description : Steam Sterilizer - 833HC-E,L2,DD(LHRH),EJ-SST,DU,PFM,HC,RLR,REC,-,-,-

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 700 Series - 05902533511723 Catalog Number : 7MRPUPHTAAAA

Device Description : Steam Sterilizer - 733HC-E,L2,SDRH,EJ SST,DU,PWR,TRK,REC

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 400 Series - 05902533511730 Catalog Number : 4SSVUMHRAWAA

Device Description : Steam Sterilizer – 433HC-E,L1,SD,EJ,DU,MAN,HC,R+2,REC,380

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

Getinge 500 Series - 05902533511747 Catalog Number : 5SSPUPHTAKAA

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

Device Class : 2

Duns Number: 427370513

Premarket Exempt : No

Product Code : FLE

Prescription Use : No

Device Count : 1

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