Identity
- Device Name
- T Com EUDAMED
- Model / Reference
- T Com A2E EUDAMEDFP1025A2E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800032401286 EUDAMED
- Basic UDI-DI
- B-08800032401286 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
T Com by Nexobio Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800032401286 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nexobio Co., Ltd.
- EUDAMED SRN
- KR-MF-000043543
- Authorised Representative
- Mega Diş Deposu /Mustafa Soydan-Mete Yılmaz TR-AR-000040213
Sources (1)
- EUDAMED 138ead13-bcbb-438b-a1df-3497fb1f2ebb 61 fields · synced Jun 18, 2026