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Beckman Coulter Flow cytometer
EUDAMEDClass A (EU MDR)
Ref B67516Model DxFLEXRef B67523Ref D08973Ref C02846Ref B67528Ref B67518Ref C44326
Identity
- Trade Name
- Beckman Coulter Flow cytometer EUDAMED
- Device Name
- Flow cytometer EUDAMED
- Model / Reference
- DxFLEX EUDAMEDB67516 EUDAMEDB67523 EUDAMEDD08973 EUDAMEDC02846 EUDAMEDB67528 EUDAMEDB67518 EUDAMEDC44326 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590748593 EUDAMED15099590748623 EUDAMED15099590787707 EUDAMED15099590717834 EUDAMED15099590748012 EUDAMED15099590748609 EUDAMED15099590738587 EUDAMED
- Basic UDI-DI
- 150995907DxFLEXVE EUDAMED
- EMDN Code
- W0202040180 CYTOFLOWMETERS - HARDWARE ACCESSORIES EUDAMEDW02020499 FLOW CYTOMETRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMEDNetherlands 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
Beckman Coulter Flow cytometer by Beckman Coulter Biotechnology 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 | 150995907DxFLEXVE | Class A | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000011854
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (7)
- EUDAMED e776b2ba-cc28-44f9-9351-e5ec15327518 61 fields · synced Jul 27, 2026
- EUDAMED a3460ac3-b67c-4ef5-9958-78952337de9d 61 fields · synced May 16, 2026
- EUDAMED 9b5c1c9b-562c-4240-84f3-5cf9cd7237a8 61 fields · synced May 17, 2026
- EUDAMED 767932c2-2bc7-497a-be0a-932537dd7213 61 fields · synced May 17, 2026
- EUDAMED f0f6bcfc-de14-4c0a-b334-fcb1a148a7dc 61 fields · synced May 17, 2026
- EUDAMED 1c5524bd-99e9-42f5-a268-f9fea8d90400 61 fields · synced May 18, 2026
- EUDAMED b4be8b67-fc51-46c6-947b-9f519c76e2ad 61 fields · synced May 18, 2026