E.M.S. Electro Medical Systems S.A.

Address:RTE DE CHAMP-COLIN 2,NYON Vaud,CH

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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

Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (6) Lithotriptor, Electro-Hydraulic (FFK) (4)

Premarket Exempt

No Yes

Clear

Swiss LithoClast Select - 07613353000394 Catalog Number : M0068403010

Device Description : Swiss LithoClast® Select Console

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353000448 Catalog Number : M0068407030

Device Description : Foot pedal LithoClast Master

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353000493 Catalog Number : M0068403040

Device Description : Vario Ultrasound Handpiece Kit

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353000509 Catalog Number : M006840304R0

Device Description : Ultrasound LithoClast Handpiece BSC

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353000523 Catalog Number : M0068403060

Device Description : Lateral suction connector BSC

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353000530 Catalog Number : M0068403070

Device Description : Combination suction connector BSC

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353000554 Catalog Number : M0068403160

Device Description : Combination suction connector Ø8

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353000561 Catalog Number : M0068403170

Device Description : Straight suction connector Ø8

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353001223 Catalog Number : EL-211

Device Description : Suction tube Ø4,0 x 353 mm (12 Ch.)

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

LithoClast - 07613353001230 Catalog Number : EL-212

Device Description : Suction tube Ø3,5x380mm (10,5 Ch.)

Device Class : 2

Duns Number: 481233849

Premarket Exempt : No

Product Code : GCX

Prescription Use : Yes

Device Count : 1

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