Identity
- Device Name
- Dental Accessory EUDAMED
- Model / Reference
- 260-103-025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00813110024725 EUDAMED
- Basic UDI-DI
- 081311002ACC42 EUDAMEDB-00813110024725 EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Dental Accessory by Bicon, Llc — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 081311002ACC42 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081311002ACC42 | Class I | Active |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (2)
- EUDAMED 3a227e91-3100-4e2d-a5ac-030e2594824d 61 fields · synced Jul 15, 2026
- EUDAMED e0f53dec-bfe5-4f56-9bd6-c2b5e56901ce 61 fields · synced May 19, 2026