← Back to catalogue
NovoCyte Quanteon Dx Flow Cytometer
EUDAMEDClass A (EU MDR)
Ref 2010257D, 2010258D, 2010259D,2010257CE, 2010258CE, 2010259CEModel NovoCyte Quanteon Dx VBYR
Identity
- Trade Name
- NovoCyte Quanteon Dx Flow Cytometer EUDAMED
- Device Name
- NovoCyte Quanteon Dx Flow Cytometer EUDAMED
- Model / Reference
- NovoCyte Quanteon Dx VBYR EUDAMED2010257D, 2010258D, 2010259D,2010257CE, 2010258CE, 2010259CE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974501890009 EUDAMED
- Basic UDI-DI
- 69745018900A000201UG EUDAMED
- Direct Marketing DI
- 06974501890009 EUDAMED
- EMDN Code
- W02020499 FLOW CYTOMETRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
NovoCyte Quanteon Dx Flow Cytometer by Agilent Biosciences (Hangzhou) Co., 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 | 69745018900A000201UG | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agilent Biosciences (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013066
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (2)
- EUDAMED 836c66f7-416f-4736-98d6-ea04ad69563b 61 fields · synced Aug 2, 2026
- EUDAMED 836c66f7-416f-4736-98d6-ea04ad69563b-1 61 fields · synced Jun 9, 2026