Identity
- Trade Name
- OMNIgene GUT EUDAMED
- Device Name
- OMNIgene GUT EUDAMED
- Model / Reference
- OM-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00627595000514 EUDAMED
- Basic UDI-DI
- 0627595G0700HF EUDAMED
- 510(k) Number
- DEN200040 FDA 510(k)
- FDA Product Code
- QPO FDA 510(k)
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.2952 FDA 510(k)
- Regulation Number
- 866.2952 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
OMNIgene GUT by DNA Genotek Inc — Class A — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN200040 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 0627595G0700HF | Class A | Active |
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Manufacturer
- Manufacturer
- DNA Genotek Inc.
- EUDAMED SRN
- CA-MF-000003486
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED e97a6e8e-c41c-4714-965b-dc775287b3b3 61 fields · synced Jul 25, 2026
- FDA 510(k) DEN200040 24 fields · synced May 18, 2026