Identity
- Trade Name
- FlexDam Light Curing Gingiva Barrier EUDAMED
- Device Name
- FlexDam Light Curing Gingiva Barrier EUDAMED
- Model / Reference
- 0379 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698907693795 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
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
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 7fa6c1aa-2cc9-4831-a9c0-d701f2de6ab7 61 fields · synced Oct 9, 2026