Identity
- Trade Name
- GI Genius™ Module 100 EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image interpretive unit FDA UDI
- Device Name
- GI Genius™ Module 100 EUDAMED
- Model / Reference
- GGM100 EUDAMEDGGM100.US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055060110253 EUDAMED08055060110314 FDA UDI
- Basic UDI-DI
- 805506011HW1EP EUDAMED
- Direct Marketing DI
- 08055060110253 EUDAMED
- 510(k) Number
- K233964 FDA UDI
- FDA Product Code
- QNP FDA UDI
- EMDN Code
- Z12029080 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Endoscopic video image interpretive unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1520 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: Endoscopic video image interpretive unit
GI Genius™ Module 100 by Linkverse Srl — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 300 — LINKVERSE SRL · Class II
Cleared under the same submission
K233964 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI cd3880f0-6d16-4760-923d-d700a8c7e043 34 fields · synced Jul 16, 2026
- EUDAMED af267487-94dc-4430-9276-f9fb33b54397 61 fields · synced Jul 16, 2026