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Dentsply Sirona
EUDAMEDClass IIa (EU MDR)
Ref B00GSIQ000KITModel AEU-65-ROWRef B00GSIQ000BASRef BNSGSIQA0020G
Identity
- Trade Name
- Dentsply Sirona EUDAMED
- Device Name
- CORDLESS OBTURATION SYSTEM, GUTTA SMART - ROW EUDAMED
- Model / Reference
- AEU-65-ROW EUDAMEDB00GSIQ000KIT EUDAMEDB00GSIQ000BAS EUDAMEDBNSGSIQA0020G EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D099B00GSIQ000KIT0 EUDAMED+D099B00GSIQ000BAS0 EUDAMED+D099BNSGSIQA0020G0 EUDAMED
- Basic UDI-DI
- ++D099endotherapydeviceL2 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Dentsply Sirona by Aseptico, Inc. — Class IIa — 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 | ++D099endotherapydeviceL2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aseptico, Inc.
- EUDAMED SRN
- US-MF-000014012
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 6296f29a-de75-47a1-b9cd-b4b6f0500b63 61 fields · synced Aug 1, 2026
- EUDAMED a85b7eba-972b-4929-b179-3f27b3f55e3a 61 fields · synced May 19, 2026
- EUDAMED d229d368-e825-402f-ab3b-cc98bec8bfac 61 fields · synced Aug 1, 2026