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IntelliPrep TRIO 240 Sample Preparation System
EUDAMEDClass A (EU MDR)
Ref 80042Model TRIO240
Identity
- Trade Name
- IntelliPrep TRIO 240 Sample Preparation System EUDAMED
- Device Name
- IntelliPrep TRIO 240 Sample Preparation System EUDAMED
- Model / Reference
- TRIO240 EUDAMED80042 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719882810046 EUDAMED
- Basic UDI-DI
- 471988281SamplePrepFE EUDAMED
- EMDN Code
- W02060199 ROBOTIC SAMPLE PROCESSING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
IntelliPrep TRIO 240 Sample Preparation System by PlexBio 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 | 471988281SamplePrepFE | Class A | Active |
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Manufacturer
- Manufacturer
- PlexBio Co., Ltd.
- EUDAMED SRN
- TW-MF-000031803
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED a34fdb1a-ae59-40d9-8c45-bb0d17b0fbe2 61 fields · synced Jun 17, 2026