Identity
- Trade Name
- FlexDam Light Curing Gingiva Barrier EUDAMED
- Device Name
- FlexDam Light Curing Gingiva Barrier EUDAMED
- Model / Reference
- 0374 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698907693740 EUDAMED
- Basic UDI-DI
- 869890769374UW EUDAMED
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Gingival retraction cord, non-medicated
FlexDam Light Curing Gingiva Barrier by İnci̇ Dental Tibbi̇ Malzeme San. Ve Ti̇c. Ltd. Şti̇. — Class I — 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 | 869890769374UW | Class I | Active |
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Manufacturer
- EUDAMED SRN
- TR-MF-000029487
Sources (1)
- EUDAMED 91209333-62bf-45ac-938c-f2d525476826 61 fields · synced Oct 7, 2026