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Avanti J-15, IVD
EUDAMEDClass A (EU MDR)
Ref C01994Model Avanti J-15 series centrifuge
Identity
- Trade Name
- Avanti J-15, IVD EUDAMED
- Device Name
- Avanti J-15, Avanti J-15R EUDAMED
- Model / Reference
- Avanti J-15 series centrifuge EUDAMEDC01994 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590697525 EUDAMED
- Basic UDI-DI
- 150995901AVANTIJ15FZ 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
Avanti J-15, 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 | 150995901AVANTIJ15FZ | 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 8026b096-460f-460e-b7f7-a9ad66f1bee9 61 fields · synced Jul 14, 2026