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Dentsply
EUDAMEDClass IIa (EU MDR)
Ref A13000000000Model AEU-55MRef V040541000000Model AEU-55VDW
Identity
- Trade Name
- Dentsply EUDAMED
- Device Name
- Calamus Dual EUDAMEDBEEFILL 2 IN 1 EUDAMED
- Model / Reference
- AEU-55M EUDAMEDA13000000000 EUDAMEDAEU-55VDW EUDAMEDV040541000000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D099A130000000000 EUDAMED+D099V0405410000000 EUDAMED
- Basic UDI-DI
- B-+D099A130000000000 EUDAMEDB-+D099V0405410000000 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMEDEUDAMED
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-+D099A130000000000 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
- EUDAMED SRN
- US-MF-000014012
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 2264ebc8-c6a9-4256-98c6-d0559b040118 61 fields · synced Jul 12, 2026
- EUDAMED fc5b4f3e-ba89-43ef-bc6a-222b6cf68c52 61 fields · synced May 18, 2026