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M3-Tp
EUDAMEDClass IIa (EU MDR)
Ref MTP0000021A01Model L/CCEU/CCP/ONE/Mr/RT/OQF/OQFL/Path/GTP/GTPL/T/TE/MAX/AF F ONE/SPathL/Dual Shape One/Shadow/RETREATMENT/Easy Plus/Easy Wave/Easy Baby/Easy Retreatment/Easy Opener/Easy Path/Easy Flex
Identity
- Trade Name
- M3-TP EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- L/CCEU/CCP/ONE/Mr/RT/OQF/OQFL/Path/GTP/GTPL/T/TE/MAX/AF F ONE/SPathL/Dual Shape One/Shadow/RETREATMENT/Easy Plus/Easy Wave/Easy Baby/Easy Retreatment/Easy Opener/Easy Path/Easy Flex EUDAMEDMTP0000021A01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942135212535 EUDAMED
- Basic UDI-DI
- 697312285UDGRCF002N7 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-Tp 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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- 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 | 697312285UDGRCF002N7 | 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 f6c2202c-e3dd-4c3d-9131-5b23697b2432 61 fields · synced Jun 19, 2026