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RevoDx Bacterial Respiratory Pathogen Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202603-50
Identity
- Trade Name
- RevoDx Bacterial Respiratory Pathogen Detection Kit EUDAMED
- Device Name
- RevoDx Bacterial Respiratory Pathogen Detection Kit EUDAMED
- Model / Reference
- IP202603-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387214360 EUDAMED
- Basic UDI-DI
- B-08684387214360 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Cyprus 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 Bacterial Respiratory 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-08684387214360 | 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 402c7d13-c95a-4525-8b7d-d6331a796e99 61 fields · synced Jun 18, 2026