Identity
- Trade Name
- GeneMind EUDAMED
- Device Name
- Analysis Software for Drug Resistance Detection in Tuberculosis EUDAMED
- Model / Reference
- MTBseq_analysis EUDAMEDL000121 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968584077 EUDAMED
- Basic UDI-DI
- B-06974968584077 EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Türkiye 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
GeneMind by GeneMind Biosciences Co., Ltd. — 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-06974968584077 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED d0ddc03b-70d2-425a-ac60-b62e5f4d8b80 61 fields · synced Jun 19, 2026