Identity
- Trade Name
- EsCem A2 EUDAMED
- Device Name
- EsCem EUDAMED
- Model / Reference
- EsCem A2 EUDAMED#3805A2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262953602 EUDAMED
- Basic UDI-DI
- B-08809262953602 EUDAMED880926295ESCSM EUDAMED
- Direct Marketing DI
- 08809262953602 EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER 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
EsCem A2 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-08809262953602 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809262953602 | 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 eff4d289-5a8c-44c2-b6d8-bc250723a338 61 fields · synced Jul 15, 2026
- EUDAMED 0aeef7f2-50c5-4f54-91e3-3a639e371b5c 61 fields · synced Jul 15, 2026