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NG-Test CARBA 5
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref NGB-CAR-S23-021510(k) K191889
by NG Biotech
Identity
- Trade Name
- NG-Test CARBA 5 EUDAMED
- Device Name
- NG-TEST CARBA-5 EUDAMED
- Model / Reference
- NGB-CAR-S23-021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701077401499 EUDAMED
- Basic UDI-DI
- B-03701077401499 EUDAMED
- EMDN Code
- W010407 MICROBIOLOGY RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
NG-Test CARBA 5 by Ng Biotech — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191889 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-03701077401499 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- NG Biotech
- EUDAMED SRN
- FR-MF-000016216
Sources (2)
- EUDAMED 7411e7bf-db76-41b2-8c24-670e36bd513d 85 fields · synced Jun 18, 2026
- FDA 510(k) K191889 1 fields · synced May 18, 2026