GI Genius™ Module 200
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- GI Genius™ Module 200 EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image interpretive unit FDA UDI
- Device Name
- GI Genius™ Module 100 EUDAMED
- Model / Reference
- GGM100 EUDAMEDGGM200 EUDAMEDGGM200.US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055060110260 EUDAMED08055060110321 FDA UDI
- Basic UDI-DI
- 805506011HW1EP EUDAMED
- Direct Marketing DI
- 08055060110260 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic video image interpretive unit
GI Genius™ Module 200 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
MDR
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 |
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Manufacturer
- Manufacturer
- Linkverse Srl
Sources (2)
- FDA UDI 3d0ff1e8-99eb-4586-a2a3-a41dd39ea9fa 34 fields · synced Jul 8, 2026
- EUDAMED d77c2f2b-d4b4-4cb3-8999-7ee005ce3ee8 61 fields · synced Jul 8, 2026