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RevoDx Meningitis/Encephalitis Pathogen PLUS Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202426-12Ref IP202426-48slRef IP202426-24slRef IP202426-24sh
Identity
- Trade Name
- RevoDx Meningitis/Encephalitis Pathogen PLUS Detection Kit EUDAMED
- Device Name
- RevoDx Meningitis/Encephalitis Pathogen PLUS Detection Kit EUDAMED
- Model / Reference
- IP202426-12 EUDAMEDIP202426-48sl EUDAMEDIP202426-24sl EUDAMEDIP202426-24sh EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387211536 EUDAMED08684387211581 EUDAMED08684387211567 EUDAMED08684387211574 EUDAMED
- Basic UDI-DI
- B-08684387211536 EUDAMEDB-08684387211581 EUDAMEDB-08684387211567 EUDAMEDB-08684387211574 EUDAMED
- EMDN Code
- W0105070505 MENINGITIS / ENCEPHALITIS 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 Meningitis/Encephalitis Pathogen PLUS 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-08684387211536 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (4)
- EUDAMED a727e062-e531-40c3-a393-4f231b7c6db7 61 fields · synced Oct 6, 2026
- EUDAMED 05727a01-a999-4e90-9eb3-b2855301a4b8 61 fields · synced May 17, 2026
- EUDAMED f7cc8b72-c253-45b4-a797-3acc87e49baf 61 fields · synced May 17, 2026
- EUDAMED 92bc04da-d30b-4d0e-a25e-277b6ddd2f07 61 fields · synced May 17, 2026