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RevoDx HPV 26 Screening Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202222-25Ref IP202222-100
Identity
- Trade Name
- RevoDx HPV 26 Screening Kit EUDAMED
- Device Name
- RevoDx HPV 26 Screening Kit EUDAMED
- Model / Reference
- IP202222-25 EUDAMEDIP202222-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683079717332 EUDAMED08683079717349 EUDAMED
- Basic UDI-DI
- B-08683079717332 EUDAMEDB-08683079717349 EUDAMED
- EMDN Code
- W0105041002 SCREENING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMEDAustria 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 HPV 26 Screening Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — 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-08683079717332 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (2)
- EUDAMED 1389c1fa-3739-4c0f-a19f-40d0d9fed073 61 fields · synced Oct 6, 2026
- EUDAMED a01e80c5-1ce1-4f40-b462-cb1db05aca45 61 fields · synced May 17, 2026