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RevoDx Respiratory-5 Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202342-48Ref IP202342-12
Identity
- Trade Name
- RevoDx Respiratory-5 Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx Respiratory-5 Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202342-48 EUDAMEDIP202342-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387210256 EUDAMED08684387212489 EUDAMED
- Basic UDI-DI
- B-08684387210256 EUDAMEDB-08684387212489 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT 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 Respiratory-5 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-08684387210256 | 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 a0a648b5-3b0d-4b4a-be28-a7454dc7ed79 61 fields · synced Oct 6, 2026
- EUDAMED 027ce6ed-57eb-4f8a-9bc3-45d41900f0aa 61 fields · synced May 18, 2026