Identity
- Trade Name
- Supertract 20 EUDAMED
- Device Name
- Gingival Retraction Paste EUDAMED
- Model / Reference
- Supertract EUDAMEDEDST-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809370410370 EUDAMED
- Basic UDI-DI
- 88093704100137B EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
Supertract 20 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 | 88093704100137B | Class I | Active |
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Manufacturer
- Manufacturer
- EASTDENT Co., Ltd
- EUDAMED SRN
- KR-MF-000022583
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED 7a1679f5-3e86-4f67-a588-14d39d8acf9f 61 fields · synced Aug 2, 2026