Identity
- Device Name
- Endo files EUDAMED
- Model / Reference
- H50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975783731608 EUDAMED
- Basic UDI-DI
- 697578373EF001KJ EUDAMED
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
The Endo Files are a revolutionary medical device designed to provide high-quality, precise tissue removal for various surgical procedures. With its advanced technology and sterile design, it is an ideal solution for clinicians seeking to improve patient outcomes.
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 | 697578373EF001KJ | Class I | Active |
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Manufacturer
- Manufacturer
- Baru Foshan Medical Technology Co., Limited
- EUDAMED SRN
- CN-MF-000045880
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 147feb63-0418-45c7-87a7-9745968385e7 61 fields · synced Oct 6, 2026