Leica Microsystems (Schweiz) AG

Address:MAX SCHMIDHEINY-STRASSE 201,HEERBRUGG Sankt Gallen,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

MICROSCOPE, SURGICAL (EPT) (3) CAMERA, STILL, SURGICAL (FTT) (2) MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC (HRM) (1) System, x-ray, angiographic (IZI) (1)

Premarket Exempt

No Yes

Clear

Leica HD C100 - 07630003593488 Catalog Number :

Device Description : Leica HD C100 for OHs - Accessory for Leica surgical operating microscope systems

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FTT

Prescription Use : Yes

Device Count : 1

Leica HD C100 - 07630003593495 Catalog Number :

Device Description : Leica HD C100 for all microscopes except OHs - Accessory for Leica surgical oper Leica HD C100 for all microscopes except OHs - Accessory for Leica surgical operating microscope systems

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FTT

Prescription Use : Yes

Device Count : 1

Leica FL800 ULT - 07630003593587 Catalog Number :

Device Class : 2

Duns Number: 480198725

Premarket Exempt : No

Product Code : IZI

Prescription Use : Yes

Device Count : 1

PROvido - 07630003594416 Catalog Number :

Device Description : PROvido stand (Premium) - for Leica surgical operating microscope system: PROvido

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

PROvido - 07630003594423 Catalog Number :

Device Description : PROvido Stand (Standard) - for Leica surgical operating microscope system: PROvido

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

ARveo 8 - 07630003598872 Catalog Number :

Device Description : ARveo 8 stand system for M530 microscope - for Leica surgical operating microsco ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

PROVEO 8 F42 - 07630003599008 Catalog Number :

Device Description : PROVEO 8 Stand F42, OCT Ready variant - for Leica surgical operating microscope PROVEO 8 Stand F42, OCT Ready variant - for Leica surgical operating microscope system: PROVEO 8

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : HRM

Prescription Use : Yes

Device Count : 1

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