Leica Microsystems (Schweiz) AG

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

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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, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC (HRM) (4) MICROSCOPE, SURGICAL (EPT) (3) Keratoscope, ac-powered (HLQ) (1) MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY (FSO) (1) System, x-ray, angiographic (IZI) (1)

Premarket Exempt

Yes No

Clear

M320 LW12 - 07630003566536 Catalog Number :

Device Description : Wall mount LW12 for M320 - for Leica surgical operating microscope system: M320 LW12

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

M320 Optics Carrier - 07630003566543 Catalog Number :

Device Description : M320 Optics Carrier, Swing arm short, inclined - for Leica surgical operating mi M320 Optics Carrier, Swing arm short, inclined - for Leica surgical operating microscope systems: M320 FP12, M320 F12, M320 TP12, M320 LW12, M320 TC12

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

RUV800 WD175 - 07630003567717 Catalog Number :

Device Description : RUV800 WD175 - Accessory for Leica surgical operating microscope systems

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : HRM

Prescription Use : Yes

Device Count : 1

Leica RUV800 WD200 - 07630003567724 Catalog Number :

Device Description : RUV800 WD200 - Accessory for Leica surgical operating microscope systems

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : HRM

Prescription Use : Yes

Device Count : 1

M822 Optics Carrier - 07630003568707 Catalog Number :

Device Description : M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 M822 Set Optics Carrier - for Leica surgical operating microscope systems: M822 F20, M822 F40, M822 C40, M822 CT40

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : HRM

Prescription Use : Yes

Device Count : 1

M844 F20 / M822 F20 - 07630003568752 Catalog Number :

Device Description : F20 stand system for M844 / M822 - for Leica surgical operating microscope syste F20 stand system for M844 / M822 - for Leica surgical operating microscope systems: M844 F20, M822 F20

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : FSO

Prescription Use : Yes

Device Count : 1

Leica DI C800 - 07630003569445 Catalog Number :

Device Description : Leica DI C800 - Accessory for Leica surgical operating microscope systems

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : HRM

Prescription Use : Yes

Device Count : 1

M320 C12 - 07630003570601 Catalog Number :

Device Description : C12 Ceiling Mount for M320 - for Leica surgical operating microscope system: M320 C12

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : EPT

Prescription Use : Yes

Device Count : 1

Leica Keratoscope - 07630003570908 Catalog Number :

Device Description : Leica Keratoscope - Accessory for Leica surgical operating microscope systems

Device Class : 1

Duns Number: 480198725

Premarket Exempt : Yes

Product Code : HLQ

Prescription Use : Yes

Device Count : 1

LEICA FL800 - 07630003575125 Catalog Number :

Device Class : 2

Duns Number: 480198725

Premarket Exempt : No

Product Code : IZI

Prescription Use : Yes

Device Count : 1

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