Identity
- Trade Name
- Allday EUDAMED
- Device Name
- Allday Dry Mouth Gel EUDAMEDAllday Dry Mouth Spray EUDAMED
- Model / Reference
- 626EUG210 EUDAMED626EU0210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858290006857 EUDAMED00858290006864 EUDAMED
- Basic UDI-DI
- 00858290006626EUG21039 EUDAMED00858290006626EU0210WC EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Allday by Elevate Oral Care, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00858290006626EUG21039 | Class I | Active |
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Manufacturer
- Manufacturer
- Elevate Oral Care, LLC
- EUDAMED SRN
- US-MF-000037860
- Authorised Representative
- QDossier B.V. NL-AR-000033747
Sources (2)
- EUDAMED da4e7ee0-a0b8-4f60-99a6-fe7118b6bd6e 61 fields · synced Jul 14, 2026
- EUDAMED 8c56ab3a-5c27-4393-b4c6-3039e1ef92d7 61 fields · synced May 18, 2026