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RevoDx Gastro Bacterial Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202403-12
Identity
- Trade Name
- RevoDx Gastro Bacterial Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx Gastro Bacterial Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202403-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387212854 EUDAMED
- Basic UDI-DI
- B-08684387212854 EUDAMED
- EMDN Code
- W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
RevoDx Gastro Bacterial Pathogen Detection Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED
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-08684387212854 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (1)
- EUDAMED 12659a5d-8b7e-49fd-868b-a189f2c8d6d2 61 fields · synced Oct 6, 2026