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EsCom250 System Kit
EUDAMEDClass IIa (EU MDR)
Ref #3203P05Ref #3203P04M
by Spident
Identity
- Trade Name
- EsCom250 System Kit EUDAMEDEsCom250 System Kit (4s) EUDAMED
- Device Name
- EsCom250 EUDAMED
- Model / Reference
- #3203P05 EUDAMED#3203P04M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809262953466 EUDAMED08809262950755 EUDAMED
- Basic UDI-DI
- 880926295ECMRR EUDAMED
- Direct Marketing DI
- 08809262953466 EUDAMED08809262950755 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
EsCom250 System Kit by Spident — Class IIa — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880926295ECMRR | 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 3b0cc3f7-9f05-4e43-a4c1-b244b8495d98 61 fields · synced Jul 10, 2026
- EUDAMED e52add0b-b51d-4192-b752-d9fd8daf56be 61 fields · synced May 18, 2026