Prostalund AB

Address:Scheelevagen 19,LUND Skane,SE

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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

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy (MEQ) (8) Needle, Aspiration And Injection, Disposable (GAA) (1)

Premarket Exempt

No Yes

Clear

CoreTherm - 07350081910013 Catalog Number : AN806001

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreTherm - 07350081910020 Catalog Number : IP807601

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreTherm - 07350081910037 Catalog Number : RP809601

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreTherm - 07350081910044 Catalog Number : SP808601

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreTherm - 07350081910051 Catalog Number : CA804220

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreTherm - 07350081910068 Catalog Number : AN806101

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreTherm - 07350081910075 Catalog Number : IP807101

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreTherm - 07350081910082 Catalog Number : CA804120

Device Class : 3

Duns Number: 554703897

Premarket Exempt : No

Product Code : MEQ

Prescription Use : No

Device Count : 1

CoreBloc - 07350081910099 Catalog Number : SK820000

Device Class : 1

Duns Number: 554703897

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : No

Device Count : 1

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