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RevoDx Respiratory-24 Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202323Ref IP202323-24Ref IP202323-24sh
Identity
- Trade Name
- RevoDx Respiratory-24 Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx Respiratory-24 Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202323 EUDAMEDIP202323-24 EUDAMEDIP202323-24sh EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-8684387210188CU EUDAMED08684387210188 EUDAMED08684387211130 EUDAMED
- Basic UDI-DI
- B-8684387210188CU EUDAMEDB-08684387210188 EUDAMEDB-08684387211130 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Slovakia 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 Respiratory-24 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-8684387210188CU | 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 d71fca16-efc6-4445-bf92-9bbeed32abb9 61 fields · synced Oct 6, 2026
- EUDAMED 181355b1-ea36-4665-9fba-d46eb96f4034 61 fields · synced May 17, 2026
- EUDAMED 333642c9-2d83-485f-92f6-34e8cff30ec0 61 fields · synced May 19, 2026