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cobas® eplex respiratory pathogen panel 3 (RP3)
EUDAMEDFDA 510(k)Class B (EU MDR)
Ref 10246944001
Identity
- Trade Name
- cobas® eplex respiratory pathogen panel 3 (RP3) EUDAMED
- Device Name
- cobas® eplex respiratory pathogen panel 3 (RP3) EUDAMED
- Model / Reference
- 10246944001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857167005399 EUDAMED
- Basic UDI-DI
- 085716700510246944001PN EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
cobas® eplex respiratory pathogen panel 3 (RP3) by GenMark Diagnostics — Class B — 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 | K163636 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 085716700510246944001PN | Class B | Active |
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Manufacturer
- Manufacturer
- GenMark Diagnostics
- EUDAMED SRN
- US-MF-000010772
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d5d6d7b6-d5b9-46dc-9802-8b99554ee860 61 fields · synced Jun 20, 2026
- FDA 510(k) K163636 1 fields · synced May 18, 2026