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NiTi File 045/21mm
EUDAMEDClass I (EU MDR)
Ref 504521Model An endodontic hand instruments for root canal reparation
Identity
- Trade Name
- NiTi File 045/21mm EUDAMED
- Model / Reference
- An endodontic hand instruments for root canal reparation EUDAMED504521 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438311216393 EUDAMED
- Basic UDI-DI
- B-06438311216393 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
NiTi File 045/21mm by LM-Instruments Oy — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06438311216393 | Class I | Active |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (1)
- EUDAMED 610ee4b1-bba7-499e-912c-5fe9505a17c1 61 fields · synced Jun 18, 2026