Identity
- Trade Name
- Genedrive® System EUDAMED
- Device Name
- Genedrive® System EUDAMED
- Model / Reference
- GS-003 V4.0 EUDAMEDGS-002 V4.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060654860677 EUDAMED05060654860172 EUDAMED
- Basic UDI-DI
- 506065486GS-00X2F EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMEDGreece EUDAMED
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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
Yes
EUDAMEDEUDAMED
Genedrive® System by Genedrive Diagnostics Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 506065486GS-00X2F | Class A | Active |
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Manufacturer
- Manufacturer
- Genedrive Diagnostics Ltd.
- EUDAMED SRN
- GB-MF-000012810
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 107b9399-2a49-49dc-b118-b5a58014541c 61 fields · synced Jul 12, 2026
- EUDAMED e2ad3b1c-6db7-45fe-8bcf-3c4741f2efca 61 fields · synced May 19, 2026