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RevoDx STI-18 Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202515-12shRef IP202515-48shRef IP202515-12slRef IP202317-12Ref IP202515-12
Identity
- Trade Name
- RevoDx STI-18 Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx STI-18 Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202515-12sh EUDAMEDIP202515-48sh EUDAMEDIP202515-12sl EUDAMEDIP202317-12 EUDAMEDIP202515-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387214094 EUDAMED08684387214131 EUDAMED08684387214087 EUDAMED08684387214070 EUDAMED
- Basic UDI-DI
- B-08684387214094 EUDAMEDB-08684387214131 EUDAMEDB-08684387214087 EUDAMEDB-08684387214070 EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - 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 STI-18 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-08684387214094 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (5)
- EUDAMED 022470b8-db44-425c-9251-671ce60b4b31 61 fields · synced Oct 5, 2026
- EUDAMED b3db3bb0-04f3-4048-8820-1e4b2700a4ee 61 fields · synced May 17, 2026
- EUDAMED f8fa0786-f7de-4b00-9891-e4f92b1a5515 61 fields · synced May 18, 2026
- EUDAMED 3dfa0dbc-f58a-4d2c-9a98-70af79a043c2 61 fields · synced May 18, 2026
- EUDAMED bc8b5bc7-3766-490f-8d75-d63438ed215a 61 fields · synced Oct 5, 2026