Identity
- Trade Name
- Tender Fiber Zero EUDAMED
- Device Name
- Tender Fiber Zero EUDAMED
- Model / Reference
- TF01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EMICTF011O EUDAMED
- Basic UDI-DI
- ++EMICFAM1CVB EUDAMED
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Tender Fiber Zero by Micerium S.p.A. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063170 | Class I | Active |
| EUDAMED | European Union | CE/MDR | ++EMICFAM1CVB | Class I | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (2)
- EUDAMED 02267a2f-dae1-4eff-841a-79e42e88a253 61 fields · synced Jul 12, 2026
- FDA 510(k) K063170 1 fields · synced May 18, 2026