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BuccalFix stabilization buffer supplied as 500ml in HDPE bottle.
EUDAMEDClass A (EU MDR)
Ref BFX-500Model GeneFix DNA/RNA Collector, Non-Sterile
Identity
- Trade Name
- BuccalFix stabilization buffer supplied as 500ml in HDPE bottle. EUDAMED
- Device Name
- GeneFix DNA/RNA Collector, Non-sterile EUDAMED
- Model / Reference
- GeneFix DNA/RNA Collector, Non-Sterile EUDAMEDBFX-500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060544100265 EUDAMED
- Basic UDI-DI
- 506054410Genefix8M EUDAMED
- Direct Marketing DI
- 05060544100265 EUDAMED
- EMDN Code
- W05019002 SALIVA COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
BuccalFix stabilization buffer supplied as 500ml in HDPE bottle. by Cell Projects 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 | 506054410Genefix8M | Class A | Active |
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Manufacturer
- Manufacturer
- Cell Projects Ltd
- EUDAMED SRN
- GB-MF-000002266
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED bcb75ddb-2de2-4c21-a896-a3d4a9db1f54 61 fields · synced Jun 19, 2026