Identity
- Trade Name
- Logix Smart MTB Test Kit EUDAMED
- Device Name
- Logix Smart MTB Test Kit EUDAMED
- Model / Reference
- MTB-K-007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-MTB-K-0074D EUDAMED
- Basic UDI-DI
- B-MTB-K-0074D EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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
No
EUDAMED
Logix Smart MTB Test Kit by Co-Diagnostics, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-MTB-K-0074D | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Co-Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000036425
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED fe074223-3e1c-4e69-82fd-8bdff9b4e58c 61 fields · synced Jun 17, 2026