Identity
- Trade Name
- Fungifast EUDAMED
- Device Name
- Fungifast Assay for ONT Sequencing EUDAMED
- Model / Reference
- CGNFF001 EUDAMEDCGNFF001.100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04793002939015 EUDAMED
- Basic UDI-DI
- 4793002939FungifastXT EUDAMED
- Direct Marketing DI
- 04793002939015 EUDAMED
- EMDN Code
- W0105900299 INFECTIOUS IMMUNOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
New Device
Yes
EUDAMED
Fungifast by Credence Genomics Pvt. Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4793002939FungifastXT | Class A | Active |
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Manufacturer
- Manufacturer
- Credence Genomics Pvt. Ltd.
- EUDAMED SRN
- LK-MF-000045860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 2bda8204-aa84-4041-a3cc-7bdfaf273b93 61 fields · synced Jul 20, 2026