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RevoDx Sexually Transmitted Infections (STIs) Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202229-48sh
Identity
- Trade Name
- RevoDx Sexually Transmitted Infections (STIs) Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx Sexually Transmitted Infections (STIs) Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202229-48sh EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387211000 EUDAMED
- Basic UDI-DI
- B-08684387211000 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 Sexually Transmitted Infections (STIs) Pathogen Detection Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed…
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-08684387211000 | 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 ed2bc2d7-e5cf-4152-9c37-296e63e21783 61 fields · synced Oct 7, 2026