Identity
- Device Name
- Applicators EUDAMED
- Model / Reference
- ACEM20, F670002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D701ACEM202 EUDAMED
- Basic UDI-DI
- ++D701APPLAS EUDAMED
- Unit of Use DI
- D701ACEM201 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
Category: Dental material injection cannula, single-use
Applicators by Pulpdent Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 695bf4d4-27fd-44c2-8701-63d5a9b2eacf 61 fields · synced Jun 18, 2026
- EUDAMED 695bf4d4-27fd-44c2-8701-63d5a9b2eacf-1 61 fields · synced Jun 10, 2026