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Console

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref CNS-100

by Medical Microinstruments, Inc.

Identity

Trade Name
Console EUDAMED
Symani Surgical Robot Console FDA UDI
Generic Name
Robotic surgical arm system FDA UDI
Device Name
Symani Surgical Robot EUDAMED
An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. FDA UDI
Model / Reference
CNS-100 EUDAMEDFDA UDI
Description
An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities. FDA UDI

Identifiers

Primary DI / UDI-DI
08055713170504 EUDAMEDFDA UDI
Basic UDI-DI
805571317SymSRWF EUDAMED
Direct Marketing DI
08055713170504 EUDAMED
FDA Product Code
SAQ FDA UDI
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
GMDN Term
Robotic surgical arm system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
878.4963 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Device sterilization/disinfection container, reusable

Console by Medical Microinstruments, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union No Longer Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Microinstruments, Inc.
EUDAMED SRN
IT-MF-000013306

Sources (2)

  • EUDAMED fe9121c6-157c-4537-b12f-30e23a60f4ca 61 fields · synced Jun 18, 2026
  • FDA UDI c3086ffa-b10e-4d23-9456-8ef119ab132d 33 fields · synced May 30, 2026