Identity
- Trade Name
- cobas® eplex system EUDAMED
- Device Name
- cobas® eplex system EUDAMED
- Model / Reference
- 10107545001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857167005382 EUDAMED
- Basic UDI-DI
- 085716700510107545001KP EUDAMED
- Direct Marketing DI
- 00857167005382 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid sample preparation instrument IVD
cobas® eplex system by GenMark Diagnostics — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 085716700510107545001KP | Class A | Active |
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Manufacturer
- Manufacturer
- GenMark Diagnostics
- EUDAMED SRN
- US-MF-000010772
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d070c10f-6089-40d1-87b2-25c7d4b139af 61 fields · synced Jun 20, 2026