Identity
- Trade Name
- UnoSeal R EUDAMED
- Device Name
- VioSeal EUDAMED
- Model / Reference
- EVU000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809911111902 EUDAMED
- Basic UDI-DI
- 880926295VS47 EUDAMEDB-08809911111902 EUDAMED
- Direct Marketing DI
- 08809911111902 EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMEDBulgaria 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
UnoSeal R by Spident — Class IIa — 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 | 880926295VS47 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880926295VS47 | 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 f87ea3e3-baed-4ff0-b043-64cc759b6ace 61 fields · synced Jul 9, 2026
- EUDAMED 60a81dd0-b60e-4e75-8eba-bbbadd4622ed 61 fields · synced Jul 9, 2026