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MT Files
EUDAMEDClass IIa (EU MDR)
Ref Z4902019453106020、Z4902019453106020、Z4902019453106025、Z4902019453105030、Z4902019453104035、Z4902019453104040Model File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc
Identity
- Trade Name
- MT Files EUDAMED
- Device Name
- Dental Root-Canal Instruments EUDAMED
- Model / Reference
- File Type K(SS304)/K Files、File Type H（SS304）/H Files、Reamer Type K(SS304)/Reamers etc EUDAMEDZ4902019453106020、Z4902019453106020、Z4902019453106025、Z4902019453105030、Z4902019453104035、Z4902019453104040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942200915088 EUDAMED
- Basic UDI-DI
- 697590932SSTHandfilesJ4 EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE 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
MT Files by Shanwei Perfect Medical Instruments Co., Ltd. — Class IIa — 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 | 697590932SSTHandfilesJ4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanwei Perfect Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000033003
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 045e3491-67d2-43c2-aa60-e173c097429d 61 fields · synced Jun 11, 2026