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RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202207-500Ref IP202207-25Ref IP202207-100
Identity
- Trade Name
- RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit EUDAMED
- Device Name
- RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit EUDAMED
- Model / Reference
- IP202207-500 EUDAMEDIP202207-25 EUDAMEDIP202207-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387213325 EUDAMED08684387213301 EUDAMED08684387213318 EUDAMEDD-8683079717486E6 EUDAMED
- Basic UDI-DI
- B-08684387213325 EUDAMEDB-08684387213301 EUDAMEDB-08684387213318 EUDAMEDB-8683079717486E6 EUDAMED
- EMDN Code
- W0105070202 BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS EUDAMEDW0104080606 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMEDItaly 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 Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General…
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-08684387213325 | 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 5a495d7f-38c7-473c-b8d9-c84c0c0d0b53 61 fields · synced Oct 9, 2026
- EUDAMED 691d14fb-de45-42d0-ba85-1b2293877a28 61 fields · synced May 17, 2026
- EUDAMED 4bf77fd1-9fba-4e61-ad79-1dece0b752b4 61 fields · synced May 18, 2026
- EUDAMED 043af7cb-1aa8-4faa-a033-81c354d3c123 61 fields · synced May 19, 2026