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Dental Root Canal Files
EUDAMEDClass I (EU MDR)
Ref THP.21.080Model TK.21.006、TK.25.006、TK.31.006、TK.21.008、TK.25.008、TK.31.008、TK.21.010、TK.25.010、TK.31.010、TK.21.015、TK.25.015、TK.31.015、TK.21.020、TK.25.020、TK.31.020、TK.21.025、TK.25.025、TK.31.025、TK.21.030、TK.25.030、etc
by TiaDent Inc
Identity
- Device Name
- Dental Root Canal Files EUDAMED
- Model / Reference
- TK.21.006、TK.25.006、TK.31.006、TK.21.008、TK.25.008、TK.31.008、TK.21.010、TK.25.010、TK.31.010、TK.21.015、TK.25.015、TK.31.015、TK.21.020、TK.25.020、TK.31.020、TK.21.025、TK.25.025、TK.31.025、TK.21.030、TK.25.030、etc EUDAMEDTHP.21.080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810193177997 EUDAMED
- Basic UDI-DI
- 081019317DRCF44 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dental Root Canal Files by TiaDent Inc — 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 | 081019317DRCF44 | Class I | Active |
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Manufacturer
- Manufacturer
- TiaDent Inc
- EUDAMED SRN
- US-MF-000049704
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5924afca-1929-407d-9892-7b036d6322e2 61 fields · synced Jun 18, 2026