Identity
- Trade Name
- Dentsply EUDAMED
- Device Name
- CALAMUS DUAL NO CORD EUDAMED
- Model / Reference
- AEU-55M-NC EUDAMED31300701A010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D09931300701A0100 EUDAMED
- Basic UDI-DI
- B-+D09931300701A0100 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Dentsply by Aseptico, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+D09931300701A0100 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
- EUDAMED SRN
- US-MF-000014012
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED a352655f-4429-4269-b0ae-30725db5db2e 61 fields · synced May 22, 2026