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RevoDx Gastro Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202401-12slRef IP202401-12shRef IP202401-12
Identity
- Trade Name
- RevoDx Gastro Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx Gastro Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202401-12sl EUDAMEDIP202401-12sh EUDAMEDIP202401-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387211406 EUDAMED08684387211413 EUDAMED08684387211390 EUDAMED
- Basic UDI-DI
- B-08684387211406 EUDAMEDB-08684387211413 EUDAMEDB-08684387211390 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 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-08684387211406 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (3)
- EUDAMED 5f14a7cb-c4ec-4082-987a-179eeea53737 61 fields · synced Oct 6, 2026
- EUDAMED bbfd5726-7158-470f-b1e4-303ab656123f 61 fields · synced May 17, 2026
- EUDAMED 81090cde-3265-4e44-aad8-b4765f6ace78 61 fields · synced May 18, 2026