Identity
- Device Name
- Applicators EUDAMED
- Model / Reference
- FD50AP, F80685 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D701FD50AP2 EUDAMED
- Basic UDI-DI
- ++D701APPLAS EUDAMED
- Unit of Use DI
- D701FD50AP1 EUDAMED
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Applicators by Pulpdent Corporation — 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 | ++D701APPLAS | Class I | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- EUDAMED SRN
- US-MF-000004897
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 95e9eaff-f429-4644-9e38-4b5c4b535e96 61 fields · synced Jul 9, 2026
- EUDAMED 95e9eaff-f429-4644-9e38-4b5c4b535e96-1 61 fields · synced Jun 10, 2026