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NovoCyte Flow Cytometer
EUDAMEDClass A (EU MDR)
Ref K2609-64001, K2609AAModel D2041R,D2061R,D2111V,D2000,D2060,D2060R,D2070R,D2000V,D2070V,D2090V,D2110V,D3000,D3005,D2100YB,D3000RYB,D3000VYB
Identity
- Trade Name
- NovoCyte Flow Cytometer EUDAMED
- Device Name
- NovoCyte Flow Cytometer EUDAMED
- Model / Reference
- D2041R,D2061R,D2111V,D2000,D2060,D2060R,D2070R,D2000V,D2070V,D2090V,D2110V,D3000,D3005,D2100YB,D3000RYB,D3000VYB EUDAMEDK2609-64001, K2609AA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974501890085 EUDAMED
- Basic UDI-DI
- 69745018900A000101UB EUDAMED
- Direct Marketing DI
- 06974501890085 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 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 | 69745018900A000101UB | Class A | Active |
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Manufacturer
- Manufacturer
- Agilent Biosciences (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013066
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (2)
- EUDAMED cf61687b-100d-4003-8f70-19836ddaa26e 61 fields · synced Jul 8, 2026
- EUDAMED cf61687b-100d-4003-8f70-19836ddaa26e-1 61 fields · synced Jun 9, 2026