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Endoscope tracker EM

FDA UDI

Class II (US FDA UDI)

by Scopis GmbH

Identity

Trade Name
Endoscope tracker EM FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Device Name
The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The Endoscope tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Endoscope tracker EM is provided non-sterile and is intended to be sterilized by the user. The Endoscope tracker EM is reusable. FDA UDI
Model / Reference
1.0 FDA UDI
Description
The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The Endoscope tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Endoscope tracker EM is provided non-sterile and is intended to be sterilized by the user. The Endoscope tracker EM is reusable. FDA UDI

Identifiers

Catalog Number
U1 037 02 FDA UDI
Primary DI / UDI-DI
B057U1037020 FDA UDI
FDA Product Code
PGW FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electromagnetic surgical navigation device tracking system

Endoscope tracker EM by Scopis GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scopis GmbH

Sources (1)

  • FDA UDI 121b1ba7-5bd4-435a-bf67-5cbcd9863d9d 34 fields · synced Jun 8, 2026