Identity
- Trade Name
- Bactfast EUDAMED
- Device Name
- Bactfast Assay for ONT Sequencing EUDAMED
- Model / Reference
- CGNBF001 EUDAMEDCGNBF001.100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04793002939008 EUDAMED
- Basic UDI-DI
- 4793002939BactfastDZ EUDAMED
- Direct Marketing DI
- 04793002939008 EUDAMED
- EMDN Code
- W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS 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
Bactfast 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 | 4793002939BactfastDZ | 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 88343f0b-da4c-4f7b-a6aa-cea1222bdb7b 61 fields · synced Jul 31, 2026