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M3-Large
EUDAMEDClass IIa (EU MDR)
Ref MLTG0SX0160SXModel Pro/VTAPE/CCOP/ONE/M3RG/Easy File/Ni-W ONE RECIPROC Gold/M3-L Pros/Shadow/LB/Easy Rotary/Easy Taper Gold/Micope
Identity
- Trade Name
- M3-Large EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- Pro/VTAPE/CCOP/ONE/M3RG/Easy File/Ni-W ONE RECIPROC Gold/M3-L Pros/Shadow/LB/Easy Rotary/Easy Taper Gold/Micope EUDAMEDMLTG0SX0160SX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942135212924 EUDAMED
- Basic UDI-DI
- 697312285UDGRCF001N5 EUDAMED
- EMDN Code
- L159004 ENDODONTIC RASPS AND FILES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Manual endodontic file/rasp, reusable
M3-Large by United Dental Changzhou — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual endodontic file/rasp, reusable.
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- ProFile .04 Taper Hand File — TULSA DENTAL PRODUCTS LLC · Class I
- KOMET Root Canal Files — Gebr. Brasseler GmbH & Co. KG · Class I
- Endodontic Files — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class IIa
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 | 697312285UDGRCF001N5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- United Dental Changzhou
- EUDAMED SRN
- CN-MF-000018453
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 6ed123d0-eb37-4ba0-aaf8-d8d92643003a 61 fields · synced Jul 15, 2026