Identity
- Trade Name
- Smartdent Applikatoren lila ultrafein EUDAMED
- Device Name
- Mikro-Applikatoren EUDAMED
- Model / Reference
- 117516 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260044630236 EUDAMED
- Basic UDI-DI
- 4260044630024X EUDAMED
- Direct Marketing DI
- 04260044630236 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Smartdent Applikatoren lila ultrafein by Zantomed GmbH — 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 | 4260044630024X | Class I | Active |
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Manufacturer
- Manufacturer
- Zantomed GmbH
- EUDAMED SRN
- DE-MF-000009550
Sources (1)
- EUDAMED 610123dd-a4fd-4d4c-bd7e-fb3382e9a8a9 61 fields · synced Jun 18, 2026