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RevoDx TORCH qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202412-12Ref IP202412-48
Identity
- Trade Name
- RevoDx TORCH qPCR Kit EUDAMED
- Device Name
- RevoDx TORCH qPCR Kit EUDAMED
- Model / Reference
- IP202412-12 EUDAMEDIP202412-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387210843 EUDAMED08684387210850 EUDAMED
- Basic UDI-DI
- B-08684387210843 EUDAMEDB-08684387210850 EUDAMED
- EMDN Code
- W0105070502 OTHER MULTIPLE INFECTIOUS - 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 TORCH qPCR Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08684387210843 | 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 9eb79b38-89f1-4772-b6e2-e6fc49802265 61 fields · synced Oct 6, 2026
- EUDAMED 5aa5d067-f118-49e9-ab10-e2428d5cc494 61 fields · synced May 18, 2026