Identity
- Device Name
- Dental Wax EUDAMED
- Model / Reference
- PWX536F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20195291014882 EUDAMED
- Basic UDI-DI
- 0195291DentalWax6U EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC 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
Dental Wax by Flexmedics — 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 | 0195291DentalWax6U | Class I | Active |
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Manufacturer
- Manufacturer
- Flexmedics
- EUDAMED SRN
- US-MF-000013090
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 7f0518cc-1f87-4431-8926-8c14bb05dadc 61 fields · synced May 23, 2026