Identity
- Trade Name
- 0.85% SALINE EUDAMED
- Device Name
- 0.85% SALINE EUDAMED
- Model / Reference
- BO0334E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05032384018918 EUDAMED
- Basic UDI-DI
- 50323840.85%SalineOLVZ EUDAMED
- EMDN Code
- W0104010306 CULTURE MEDIA IN BOTTLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
0.85% Saline by Oxoid 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 | 50323840.85%SalineOLVZ | Class A | Active |
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Manufacturer
- Manufacturer
- Oxoid Ltd
- EUDAMED SRN
- GB-MF-000016914
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED 84f9ae06-852a-4c8f-8750-cc87a56caf8a 61 fields · synced Jun 19, 2026