← Back to catalogue
Smartcord 0
EUDAMEDClass I (EU MDR)
Ref EDSC-CModel SmartcordRef EDSX-CModel Smartcord X
Identity
- Trade Name
- Smartcord 0 EUDAMEDSmartcord X 0 EUDAMED
- Device Name
- Gingival Retraction Cord EUDAMED
- Model / Reference
- Smartcord EUDAMEDEDSC-C EUDAMEDSmartcord X EUDAMEDEDSX-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809370410073 EUDAMED08809370410233 EUDAMED
- Basic UDI-DI
- 880937041001177 EUDAMED880937041001279 EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
Smartcord 0 by EASTDENT Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 880937041001177 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EASTDENT Co., Ltd
- EUDAMED SRN
- KR-MF-000022583
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 88bc3480-9dfa-49a9-bc20-f27a13c27991 61 fields · synced Jul 12, 2026
- EUDAMED c4d04c0f-3ad6-4dfd-a6a3-aa23f58a3be8 61 fields · synced Jun 14, 2026