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Scopis GmbH

US

Last updated May 25, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
341702266

Catalogue (25)

DeviceModel / ReferenceRegistriesClassStatus
Instrument clip 4 mm 1.0
FDA UDI
Class IIActive
Nova Ar 2.6.15
FDA UDI
Class IIActive
Hybrid Navigation Unit EM 2.2
FDA UDI
Class IIActive
Registration pointer EM-D 1.0
FDA UDI
Class IIActive
Instrument clamp 2-6 mm 1.0
FDA UDI
Class IIActive
Field generator mounting arm 1.0
FDA UDI
Class IIActive
Instrument clamp 6-10 mm 1.0
FDA UDI
Class IIActive
Suction tube Frazier EM 1.0
FDA UDI
Class IIActive
Instrument clamp forceps 1.0
FDA UDI
Class IIActive
Patient tracker EM-D mini 1.0
FDA UDI
Class IIActive
Universal Tracker EM 1.0
FDA UDI
Class IIActive
Precision Pointer EM 1.0
FDA UDI
Class IIActive
Instrument port 1.0
FDA UDI
Class IIActive
Calibration body EM 1.0
FDA UDI
Class IIActive
Field generator planar 1.0
FDA UDI
Class IIActive
Patient tracker tabs (PU 100) 1.0
FDA UDI
Class IIActive
Endoscope tracker EM 1.0
FDA UDI
Class IIActive
Suction tube Eicken EM 1.0
FDA UDI
Class IIActive
Instrument clamp 10-16 mm 1.0
FDA UDI
Class IIActive
NOVA Basic 2.6.8
FDA UDI
Class IIActive
Patient tracker EM mini 1.0
FDA UDI
Class IIActive
Nova Ar 2.6.16
FDA UDI
Class IIActive
Nova Ar 2.6.17
FDA UDI
Class IIActive
Scopis Extended Instrument Set EM K171661
FDA 510(k)
Class IIActive
Scopis Hybrid Navigation System EM K161491
FDA 510(k)
Class IIActive

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