Identity
- Trade Name
- Cold & Flu Guard EUDAMED
- Device Name
- Cold & Flu Guard 50 mL EUDAMED
- Model / Reference
- COLD/FLU003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060956870008 EUDAMED
- Basic UDI-DI
- B-05060956870008 EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cold & Flu Guard by Oraldent Limited — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Cold & Flu Guard
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060956870008 | Class I | Active |
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Manufacturer
- Manufacturer
- Oraldent Limited
- EUDAMED SRN
- UK-MF-000044864
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 8775cfc1-713e-4cef-b6dd-fe3f24228705 61 fields · synced Jun 18, 2026