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Genedrive® MT-RNR1 Positive Control Kit
EUDAMEDClass IVD General (EU MDR)
Ref RNR1-CTRL-02
Identity
- Trade Name
- Genedrive® MT-RNR1 Positive Control Kit EUDAMED
- Device Name
- Genedrive® MT-RNR1 Control Kit EUDAMED
- Model / Reference
- RNR1-CTRL-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060654860325 EUDAMED
- Basic UDI-DI
- B-05060654860325 EUDAMED
- EMDN Code
- W0106010199 MONOGENETIC DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Genedrive® MT-RNR1 Positive Control Kit by Genedrive Diagnostics 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-05060654860325 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genedrive Diagnostics Ltd.
- EUDAMED SRN
- GB-MF-000012810
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 69391ac4-d812-4dc9-9298-2ea6eb2f346a 61 fields · synced Jul 16, 2026