Identity
- Trade Name
- EsCom100 AO3 EUDAMED
- Device Name
- EsCom100 EUDAMED
- Model / Reference
- #3102AO3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262955347 EUDAMED
- Basic UDI-DI
- B-08809262955347 EUDAMED880926295EFZP EUDAMED
- Direct Marketing DI
- 08809262955347 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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 composite resin
EsCom100 AO3 by Spident — Class IIa — MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809262955347 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809262955347 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spident
- EUDAMED SRN
- KR-MF-000008691
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED dfefeef2-864d-4cfe-afb7-b566ca502709 61 fields · synced Sep 18, 2026
- EUDAMED 3882efa2-ab83-47a7-8a05-b3d1723c4f42 61 fields · synced Sep 18, 2026