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Optima XE – 100K (IVD)
EUDAMEDClass A (EU MDR)
Ref A99836Model Optima X series centrifuge
Identity
- Trade Name
- Optima XE – 100K (IVD) EUDAMED
- Device Name
- Optima XPN/XE series centrifuge EUDAMED
- Model / Reference
- Optima X series centrifuge EUDAMEDA99836 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590415846 EUDAMED
- Basic UDI-DI
- 150995901OPTIMALK EUDAMED
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Category: General-purpose centrifuge IVD
Optima XE – 100K (IVD) by Beckman Coulter, Inc. — 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 | 150995901OPTIMALK | Class A | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (1)
- EUDAMED 06285d09-a96d-4fde-9e9c-70329b1c991c 61 fields · synced Jun 18, 2026