Identity
- Trade Name
- Oral Care Gum Mouthwash EUDAMED
- Device Name
- Oral Care Gum Mouthwash EUDAMED
- Model / Reference
- NA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06251665002289 EUDAMED
- Basic UDI-DI
- 6251665002289XC EUDAMED
- EMDN Code
- Q01010301 DENTAL MEDICATION COMPOUNDS WITH DISINFECTANTS, ANTIBIOTICS AND ANTI-INFLAMMATORIES EUDAMED
Classification
- Device Class
- Class I 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
Oral Care Gum Mouthwash by Al-Motakadema Pharmaceutical LTD — 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 | 6251665002289XC | Class I | Active |
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Manufacturer
- Manufacturer
- Al-Motakadema Pharmaceutical LTD
- EUDAMED SRN
- JO-MF-000046386
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 129db193-4f68-4292-b42a-baca13382f5e 61 fields · synced Jul 23, 2026