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RevoDx Gastro Bacterial Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202403-48
Identity
- Trade Name
- RevoDx Gastro Bacterial Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx Gastro Bacterial Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202403-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387210324 EUDAMED
- Basic UDI-DI
- B-08684387210324 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 is a FDA-cleared, reusable medical device used for the accurate detection of gastro bacterial pathogens. This innovative tool provides reliable results in a variety of clinical settings, including food processing and pharmaceutical manufacturing.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-08684387210324 | 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 92de640f-86bc-458e-9836-69ef6a73dbe1 61 fields · synced Oct 6, 2026