GI Genius™ Module 300

FDA UDI

Class II (US FDA UDI)

by Linkverse Srl

Identity

Trade Name: GI Genius™ Module 300 FDA UDI
Generic Name: Endoscopic video image interpretive unit FDA UDI
Device Name: GI Genius™ system with software ColonPRO™. FDA UDI
Model / Reference: GGM300-US FDA UDI
Description: GI Genius™ system with software ColonPRO™. FDA UDI

Identifiers

Primary DI / UDI-DI: 08055060110338 FDA UDI
510(k) Number: K241887 FDA UDI
FDA Product Code: QNP FDA UDI
GMDN Term: Endoscopic video image interpretive unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1520 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic video image interpretive unit

GI Genius™ Module 300 by Linkverse Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic video image interpretive unit.

SKOUT system — Iterative Scopes, Inc. · Class II
GI Genius — Covidien LP · Class II
GI Genius — Covidien LP · Class II
GI Genius — Covidien LP · Class II
MAGENTIQ-COLO (ME-APDS) — MAGENTIQ EYE LTD · Class II
GI Genius — Covidien LP · Class II
SKOUT system — Iterative Scopes, Inc. · Class II
GI Genius™ Module 200 — LINKVERSE SRL · Class II

Cleared under the same submission

K241887 also covers:

ColonPRO™ 4.0 — LINKVERSE SRL
ColonPRO™ 4.0 — LINKVERSE SRL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Linkverse Srl

Sources (1)

FDA UDI e5570838-a350-4a43-ab9c-304499f2da48 35 fields · synced Jun 1, 2026