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RevoDx Entamoeba Histolytica qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202436-100Ref IP202438-100Ref IP202438-25
Identity
- Trade Name
- RevoDx Entamoeba Histolytica qPCR Kit EUDAMED
- Device Name
- RevoDx Entamoeba Histolytica qPCR Kit EUDAMED
- Model / Reference
- IP202436-100 EUDAMEDIP202438-100 EUDAMEDIP202438-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387211970 EUDAMED08684387215633 EUDAMED
- Basic UDI-DI
- B-08684387211970 EUDAMEDB-08684387215633 EUDAMED
- EMDN Code
- W0105050301 ENTAMOEBA HISTOLYTICA - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMEDTürkiye 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 Entamoeba Histolytica qPCR 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-08684387211970 | 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 bd85f220-2177-4488-8102-a157fa338070 61 fields · synced Oct 6, 2026
- EUDAMED 35d4126d-dbcd-43e1-8a88-a816db136d1d 61 fields · synced Jun 19, 2026
- EUDAMED 29a37230-4d1f-4210-9446-9843f80d21de 61 fields · synced Aug 3, 2026