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BuccalFix stabilization buffer supplied as 25ml in HDPE bottle
EUDAMEDClass A (EU MDR)
Ref BFX-25Model GeneFix DNA/RNA Collector, Non-Sterile
Identity
- Trade Name
- BuccalFix stabilization buffer supplied as 25ml in HDPE bottle EUDAMED
- Device Name
- GeneFix DNA/RNA Collector, Non-sterile EUDAMED
- Model / Reference
- GeneFix DNA/RNA Collector, Non-Sterile EUDAMEDBFX-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060544100852 EUDAMED
- Basic UDI-DI
- 506054410Genefix8M EUDAMED
- Direct Marketing DI
- 05060544100852 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 25ml 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 61b35d0c-e418-4672-9007-a0424f4df1a1 61 fields · synced Jul 9, 2026