Identity
- Device Name
- TRCR MB-Lysis Reagent EUDAMED
- Model / Reference
- 0056202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562185395280 EUDAMED
- Basic UDI-DI
- B-04562185395280 EUDAMED456018921000200273 EUDAMED
- EMDN Code
- W0105010799 MYCOBACTERIA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
TRCR MB-Lysis Reagent by Tosoh Corporation — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-04562185395280 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04562185395280 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED 0d69b13e-a3b1-4ea0-9f16-bfc4dbed0d52 61 fields · synced Jul 13, 2026
- EUDAMED 3e45a01c-7fd2-4808-ba04-562f37bec7f1 61 fields · synced May 19, 2026