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Automated TRCR Real-time Monitor TRCReady-80
EUDAMEDClass A (EU MDR)
Ref 0023950
Identity
- Trade Name
- Automated TRCR Real-time Monitor TRCReady-80 EUDAMED
- Device Name
- Automated TRCR Real-time Monitor TRCReady-80 EUDAMED
- Model / Reference
- 0023950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562185395259 EUDAMED
- Basic UDI-DI
- 45601892100040037K EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
Category: Nucleic acid sample preparation instrument IVD
Automated TRCR Real-time Monitor TRCReady-80 by Tosoh Corporation — 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 | 45601892100040037K | Class A | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (1)
- EUDAMED 17522af6-09b2-4b9c-8f78-1699df61d8f4 61 fields · synced Oct 5, 2026