Identity
- Trade Name
- EsCom100 Capsule B1 EUDAMED
- Device Name
- EsCom100 EUDAMED
- Model / Reference
- #3102B1PCS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262956627 EUDAMED
- Basic UDI-DI
- B-08809262956627 EUDAMED880926295EFZP EUDAMED
- Direct Marketing DI
- 08809262956627 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
EsCom100 Capsule B1 by Spident — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809262956627 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809262956627 | 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 5f7f74eb-3474-4cb1-8072-1a3fc2f66fb7 61 fields · synced Jun 19, 2026
- EUDAMED 78d8ca6c-1b9c-42b6-910b-e4df0e137329 61 fields · synced Jun 19, 2026