Identity
- Trade Name
- Phosphate Buffered Saline 5 Litres EUDAMED
- Device Name
- PBS Ready to use EUDAMED
- Model / Reference
- n/a EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060491270035 EUDAMED
- Basic UDI-DI
- 506049127PBSRTUD4 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Phosphate Buffered Saline 5 Litres by Sussex Biologicals Limited — 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 | 506049127PBSRTUD4 | Class A | Active |
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Manufacturer
- Manufacturer
- Sussex Biologicals Limited
- EUDAMED SRN
- GB-MF-000015922
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED c7f2dbf0-33fa-4945-9fb5-e107b389e789 61 fields · synced Oct 6, 2026